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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database
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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Study
Name
Study Status
PS010001 Medtronic Vascular Aneurx stent graft system Cardiovascular 06/13/2001 AneuRx Stent Graft System Completed
PS040001 ZOLL Circulation, Inc. Alsius coolgard 3000/coolline catheter thermal regulation system Neurology 03/05/2004 Mortality Study Completed
PS060001 Philips Medical Systems, Heartstream Philips heartstart home otc defibrillator Cardiovascular 12/07/2005 Non-Prescription Use Completed
PS060002 The Ohio State University Paragon crt 100 lens and boston vision shaping treatment (vst) lens for ook Ophthalmic 05/25/2006 Microbial Keratitis Study Completed
PS060003 Cardica, Inc. C-port distal anastomosis system General &
Plastic Surgery		 06/14/2006 Graft Patency and Technical Failure Completed
PS090001 Szabocsik and Associates Jsz orthokeratology contact lenses for overnight wear Ophthalmic 08/07/2009 Microbial Keratitis Other
PS090002 Alphatec Spine Zodiac dynamo semi-rigid spinal system Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090003 Applied Spine Technologies, Inc. Bar pedicle screw spinal fixation system Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090004 Biospine Co., Ltd. Bioflex® Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090005 DePuy Spine 6.35mm and 5.5mm peek rods Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090006 Globus Medical, Inc. Protex rods Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090007 Globus Medical, Inc. Transition stabilization system Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090008 Medtronic Cd horizon® peek rods Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090009 Medtronic Sofamor Danek Cd horizon® agile¿ dynamic stabilization device Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090010 Synthes Spine Ngarde system Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090011 Paradigm Spine Dss stabilization system Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090012 Alphatec Spine Isobar semi-rigid spinal system & dual dampener Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090013 Ulrich Medical USA Sscs hinged screws Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090014 Ulrich Medical USA Cosmic system Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090015 Exactech, Inc. Modified vertiflex spinal screw system (with dynabolt rods) Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090016 Zimmer Spine Zimmer® dynesys® spinal system with dto implant Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS090017 Zimmer Spine Zimmer® dynesys® top-loading spinal system Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Terminated
PS100001 MicroVention, Inc. Microvention hydrocoil-soft-frame Neurology 04/15/2010 HydroCoil Study Completed
HydroSoft/HydroFrame Study Completed
PS100002 Amsino International, Inc Cortez needle free iv connector General Hospital 07/21/2010 BSI rate Other
PS100003 ICU Medical, Inc. Clc2000 General Hospital 07/21/2010 BSI rate Other
PS100004 ICU Medical, Inc. Clc2000 catheter patency device General Hospital 07/21/2010 BSI rate Other
PS100005 ICU Medical, Inc. Tego General Hospital 07/21/2010 BSI rate Other
PS100006 B. Braun Medical Inc. Ultrasite valve General Hospital 07/21/2010 BSI rate Completed
PS100007 Baxter Healthcare Corporation Iv/catheter extension set with nac plus needleless access connector and nac plus needleless access connector General Hospital 07/21/2010 BSI rate Other
PS100008 Becton Dickinson Infusion Therapy Systems Bd posiflow/tm positive displacement valve General Hospital 07/21/2010 BSI rate Other
PS100009 CareFusion Maxplus tru-swab positive displacement connector General Hospital 07/21/2010 BSI rate Completed
PS100010 CareFusion Maxplus tru-swab positive displacement connector General Hospital 07/21/2010 BSI rate Completed
PS100011 Becton Dickinson Infusion Therapy Systems Nima needleless injectionsite master adapter with posiflow positive displacement feature, and iv sets General Hospital 07/21/2010 BSI rate Other
PS100012 CareFusion Ivac needle free administration sets General Hospital 07/21/2010 BSI rate Other
PS100013 CareFusion Smartsite needle free valve administration sets General Hospital 07/21/2010 BSI rate Other
PS110001 Vermillion, Inc Ova1 Immunology 01/31/2011 OVA1 Performance in Pre and Post Menopausal Women Completed
PS110002 Nexus CMF Tmj fossa-eminence/condylar prosthesis system Dental 02/04/2011 TMJ Fossa-Eminence and Condylar Pros Other
TMJ Registry Study - Total Other
PS110004 Biomet Microfixation Total temporomandibular joint replacement system Dental 02/04/2011 Time to Revision Completed
Explant Completed
PS110005 Biomet Inc. Porous titanium acetabular augments, m2a magnum 12/14 taper inserts and one-piece modular heads Orthopedic 05/06/2011 Metal Ion Levels Completed
Explant Analysis Completed
PS110006 Biomet Inc. M2a magnum 12/14 taper inserts and one-piece modular heads Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110007 Biomet Inc. Lateralized taperloc microplasty femoral components Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110008 Biomet Inc. M2a-magnum tri-spike acetabular component Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110009 Biomet Inc. Altra press-fit hip system Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110010 Biomet Inc. Altra fx hip system Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110011 Biomet Inc. Echo bi-metric press-fit stems Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110012 Biomet Inc. Parallel-sided extensively coated femoral stems Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110013 Biomet Inc. Compress segmental femoral replacement system (short spindle and anchor plug) Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110014 Biomet Inc. Metal on metal acetabular system Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110015 Biomet Inc. M2a 28mm ringloc liner Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110016 Biomet Inc. M2a acetabular system Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110017 Biomet Inc. M2a magnum system Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110018 Biomet Inc. Mallory-head modular calcar stems with interlocking slots Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110019 Biomet Inc. M2a/c2a acetabular system Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110020 Biomet Inc. Porous coated acetabular components Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110021 Biomet Inc. Compress segmental femoral replacement system Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110022 Biomet Inc. Biomet metal-on-metal hip systems- expanded contraindications Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110023 Biomet Inc. Biomet modular femoral revision system Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110024 Biomet Inc. Balance hip system Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110025 Biomet Inc. Taper 2 porous femoral stem Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110026 Biomet Inc. Ringloc + hybrid acetabular system Orthopedic 05/06/2011 Metal Ion Levels Consolidated
PS110029 DJO Global Encore clp offset total hip system, metal/metal hip system,fmp metal/metal acetabular insert, revelation stem,djo surgical revision femoral i-lip system, metal backed acetabular component, Orthopedic 05/06/2011 Clinical Study Completed
Device Retrieval Study Completed
PS110030 Encore Medical Metal/metal hip system Orthopedic 05/06/2011 Clinical Study Consolidated
Device Retrieval Study Consolidated
PS110031 Encore Medical Modification to: Fmp metal/metal acetabular insert, models 499-28, 499-34, 499-38 Orthopedic 05/06/2011 Clinical Study Consolidated
Device Retrieval Study Consolidated
PS110032 Encore Medical Fmp metal/metal acetabular insert, 499-28,449-34, 499-38 Orthopedic 05/06/2011 Clinical Study Consolidated
Device Retrieval Study Consolidated
PS110033 Encore Medical Revelation stem, model 427-21/42-080/180 Orthopedic 05/06/2011 Clinical Study Consolidated
Device Retrieval Study Consolidated
PS110034 Encore Medical Djo surgical revision femoral hip system, model 428-14/24-140/200; 428-00-050/110 Orthopedic 05/06/2011 Clinical Study Consolidated
Device Retrieval Study Consolidated
PS110035 Encore Medical Metal backed acetabular component Orthopedic 05/06/2011 Clinical Study Consolidated
Device Retrieval Study Consolidated
PS110036 Encore Medical Fmp metal/metal acetabular insert Orthopedic 05/06/2011 Clinical Study Consolidated
Device Retrieval Study Consolidated
PS110037 Johnson and Johnson ULTIMA METAL-ON-METAL ACETABULAR CUP Orthopedic 05/06/2011 Metal ion levels Other
PS110038 Johnson and Johnson Depuy pinnacle metal-on-metal acetabular cup liners Orthopedic 05/06/2011 Metal ion levels Completed
Explant Analysis Completed
PS110039 Johnson and Johnson Pinnacle metal-on-metal acetabular cup liners Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110040 Johnson and Johnson Depuy pinnacle metal-on-metal acetabular cup liner Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110041 Johnson and Johnson Depuy asr modular acetabular cup system Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110042 Johnson and Johnson Corail amt hip prosthesis Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110043 Johnson and Johnson Dupuy s-rom std hip stem prosthesis Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110044 Johnson and Johnson Depuy pinnacle metal-on-metal acetabular cup liners Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110045 Johnson and Johnson Depuy asr taper sleeve adapter Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110046 Johnson and Johnson Depuy corail amt dysplasia hip prosthesis Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110047 Johnson and Johnson Depuy tri-lock bone preservation stem Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110048 Johnson and Johnson Depuy asr xl modular acetabular cup system Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110049 Johnson and Johnson Depuy asr 300 acetabular cup system Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110050 Johnson and Johnson Depuy asphere m-spec head Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110051 Johnson and Johnson Depuy c-stem amt Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110052 Johnson and Johnson Depuy pinnacle metal-on-metal acetabular cup liners Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110053 Johnson and Johnson Depuy pinnacle 100 with gription acetabular cups Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110054 Johnson and Johnson Depuy pinnacle with gription acetabular cups Orthopedic 05/06/2011 Metal ion levels Consolidated
Explant Analysis Consolidated
PS110055 Johnson and Johnson PROFILE FEMORAL HIP Orthopedic 05/06/2011 Metal ion levels Terminated
PS110070 MicroPort Metal transcend articulation system Orthopedic 05/06/2011 Metal Ion Levels Microport Completed
Explant Completed
PS110071 MicroPort Metal transcend articulation system Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110072 MicroPort Metal transcend articulation system (larger sizes) Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110073 MicroPort Conserve plus spiked acetabular shells and conserve total 56mm femoral head Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110074 MicroPort Profemur s hip stem Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110075 MicroPort Conserve plus revision shell and conserve plus thick shell Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110076 MicroPort Profemur tapered hip stem Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110077 MicroPort Procotyl-e acetabular system Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110078 MicroPort Lineage ha acetabular shells Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110079 MicroPort Conserve plus ha acetabular shells Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110080 MicroPort Profemur renaissance hip stem Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110081 MicroPort Conserve total femoral head Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110082 MicroPort Profemur xtr hip stem Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110083 MicroPort Profemur lx hip stem Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110084 MicroPort Conserve plus quadrafix acetabular shell Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110085 MicroPort Profemur tl hip stem Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110086 MicroPort Dynasty acetabular shell and cocr acetabular liner Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110087 MicroPort Dynasty acetabular system Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110088 MicroPort Profemur lx revision 5/8 coated hip stem Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110089 MicroPort Profemur lx 5/8 coated hip stem Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110090 MicroPort Dynasty porous acetabular shell, dynasty polyethylene acetabular liner, dynasty metal acetabular liner Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110091 MicroPort Profemur hip system modular necks Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110092 Zimmer Zweymuller cup Orthopedic 05/06/2011 Metal ion levels Terminated
PS110093 Zimmer Zweymueller-sl hip prosthesis stem Orthopedic 05/06/2011 Cross-Sectional Study Completed
Explant Analysis Completed
PS110094 Zimmer Rs-cup acetabular prosthesis Orthopedic 05/06/2011 Metal ion levels Terminated
PS110096 Zimmer Converge reti-lock multi-hole reinforcement cup Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110097 Zimmer Epsilon metasul 32mm acetabular inserts, standard and hooded Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110098 Zimmer Alpha metasul 28mm and 32mm acetabular inserts, standard and hooded Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110100 Zimmer Modified anatomic porous replacement apr acetabula Orthopedic 05/06/2011 Metal ion levels Terminated
PS110101 Zimmer Schuster acetabular cup for cement/cementless fix Orthopedic 05/06/2011 Metal ion levels Terminated
PS110102 Zimmer Clx acetabular cup (wagner) for cementless fixation Orthopedic 05/06/2011 Metal ion levels Terminated
PS110105 Zimmer Apr metasul acetabular insert Orthopedic 05/06/2011 Metal ion levels Other
PS110106 Zimmer Inter-op metasul acetabular system Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110107 Zimmer Inter-op metasul hooded and protrusio acetabular inserts Orthopedic 05/06/2011 Metal ion levels Other
PS110108 Zimmer Allofit acetabular system Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110109 Zimmer Ascendent acetabular system Orthopedic 05/06/2011 Metal ion levels Other
PS110110 Zimmer Durom acetabular component and metasul ldh large diameter heads Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110111 Zimmer Zimmer porolock mis stem Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110112 Zimmer Zimmer mmc cup Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110113 Zimmer Metasul taper liners, metasul femoral heads Orthopedic 05/06/2011 Cross-sectional Plan Consolidated
Prospective Study plan Terminated
PS110114 Zimmer Zimmer threaded acetabular cup Orthopedic 05/06/2011 Metal ion levels Terminated
PS110115 Zimmer Zimmer m/l taper hip prosthesis with modular neck technology Orthopedic 05/06/2011 Cross-sectional Plan Consolidated
Prospective Study Plan Terminated
PS110116 Zimmer Zimmer m/l taper hip prosthesis with kinectiv technology system, model(s) 7848 series( modular necks), 7713 series Orthopedic 05/06/2011 Cross-sectional Plan Consolidated
Prospective Study Plan Terminated
PS110117 Zimmer Versys epoch fullcoat hip prosthesis, model 4088 series Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110118 Zimmer Zimmer m/l taper hip prosthesis with kinectiv technology system Orthopedic 05/06/2011 Cross-sectional Plan Consolidated
Prospective Study Plan Terminated
PS110119 Link America, Inc. Lidgrer-lund acetabular sockets Orthopedic 05/06/2011 Metal ion levels Terminated
PS110120 Link America, Inc. Link metal-backed acetabular cups Orthopedic 05/06/2011 Metal ion levels Terminated
PS110121 Waldemar Link GMBH & Co. KG Link cementless screw-in acetabular cup Orthopedic 05/06/2011 Metal ion levels Terminated
PS110122 Waldemar Link GMBH & Co. KG Link cementless screw-in acetabular cup Orthopedic 05/06/2011 Metal ion levels Terminated
PS110123 Orthopedic Manufacturing Co. Ace 100 degrees tubular plate Orthopedic 05/06/2011 Metal ion levels Terminated
PS110124 Advanced Bioresearch Association Natural lock acetabular component Orthopedic 05/06/2011 Metal ion levels Terminated
PS110125 Advanced Bioresearch Association Muller titanium backed acetabular cup component Orthopedic 05/06/2011 Metal ion levels Terminated
PS110126 Advanced Bioresearch Association Pm cementless screw-in acetabular cup Orthopedic 05/06/2011 Metal ion levels Terminated
PS110127 Advanced Bioresearch Association Weill cementless threaded acetabular cup Orthopedic 05/06/2011 Metal ion levels Terminated
PS110128 Advanced Bioresearch Association Freeman acetabular cup Orthopedic 05/06/2011 Metal ion levels Terminated
PS110129 American Ortomed Corp. Titanium mittelmeier type acetabular Orthopedic 05/06/2011 Metal ion levels Terminated
PS110130 American Ortomed Corp. Uniloc-cementless & self tap acetabular Orthopedic 05/06/2011 Metal ion levels Terminated
PS110131 C.R. Bard Inc. CONTOUR II LINK SP TOTAL HIP PROSTHESIS Orthopedic 05/06/2011 Metal ion levels Terminated
PS110132 Downs Surgical Ltd. RING UPM TOTAL HIP REPLACEMENT Orthopedic 05/06/2011 Metal ion levels Terminated
PS110133 Downs Surgical Ltd. MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT Orthopedic 05/06/2011 Metal ion levels Terminated
PS110134 Endomedics, Inc. SELF-ALIGNING ACETABULAR COMPONENT Orthopedic 05/06/2011 Metal ion levels Terminated
PS110135 Implantology LLC Cps acetabular component Orthopedic 05/06/2011 Metal ion levels Other
PS110136 Implantology LLC Fpc/sfpc/rfpc acetabular component Orthopedic 05/06/2011 Metal ion levels Other
PS110137 Joint Medical Products Corp. S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP Orthopedic 05/06/2011 Metal ion levels Terminated
PS110138 Joint Medical Products Corp. S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG Orthopedic 05/06/2011 Metal Ion Levels Terminated
PS110139 Med-Tek Corp. H.N. Metal backed acetabular cup, noncemented Orthopedic 05/06/2011 Metal ion levels Terminated
PS110140 Orthopaedic Device Corp. P.T.H. METAL-BACKED ACETABULAR CUP Orthopedic 05/06/2011 Metal ion levels Terminated
PS110141 Osteotechnology, Inc. Biometric screw fixation cup Orthopedic 05/06/2011 PSS Terminated
PS110142 Osteotechnology, Inc. Thompson type hip prothesis Orthopedic 05/06/2011 Metal ion levels Terminated
PS110144 Synergy Orthopaedics Intl., Inc. S.A.F. Acetabular cup Orthopedic 05/06/2011 Metal ion levels Terminated
PS110145 Techmedica, Inc. TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP Orthopedic 05/06/2011 Metal ion levels Terminated
PS110146 Turnkey Intergration USA, Inc. Modified freeman acetabular cup Orthopedic 05/06/2011 Metal ion levels Terminated
PS110147 Turnkey Intergration USA, Inc. Modified freeman revision acetabular cup Orthopedic 05/06/2011 Metal ion levels Terminated
PS110148 MicroPort Conserve bio foam shell Orthopedic 05/06/2011 Metal ion levels Consolidated
PS110149 Depuy Orthopaedics, Inc. Depuy corail hip system, revision stem Orthopedic 05/06/2011 PSS Terminated
PS120001 Acell, Inc. Acell matristem pelvic floor matrix General &
Plastic Surgery		 01/03/2012 POP AE and Effectiveness rates, registry Completed
PS120002 American Medical Systems, Inc. Ams large pore polypropylene mesh Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120003 American Medical Systems, Inc. Ams large pore polypropylene mesh Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120004 Astora Womens Health Ams elevate anterior & apical prolapse repair system with intepro llite Obstetrics/
Gynecology		 01/03/2012 POP AE and effectiveness rates, registry Other
PS120005 American Medical Systems, Inc. Ams elevate anterior & apical prolapse repair system with intepro lite Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120006 Astora Womens Health Ams elevate apical and posterior prolapse repair system with intepro lite Obstetrics/
Gynecology		 01/03/2012 POP AE and Effectiveness rates, registry Other
Elevate System w/InteXen LP Other
PS120007 American Medical Systems, Inc. Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120008 American Medical Systems, Inc. Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp Obstetrics/
Gynecology		 01/03/2012 AE and Effectiveness Rates Other
PS120009 American Medical Systems, Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix Obstetrics/
Gynecology		 01/03/2012 Apogee and Perigee System w/IntePro Lite Other
PS120010 American Medical Systems, Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix Obstetrics/
Gynecology		 01/03/2012 Apogee AE and Eff Rates Other
Perigee AE and Eff Rates Other
PS120011 American Medical Systems, Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120012 American Medical Systems, Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120013 American Medical Systems, Inc. Apogee and perigee systems with pc coated intepro lite Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120014 American Medical Systems, Inc. Elevate prolapse repair system with pc coated intepro lite- apical and posterior prolapse repair system anterior and ap Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120015 American Medical Systems, Inc. Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix Gastroenterology/
Urology		 01/03/2012 AE and effectiveness rates Other
PS120016 Synovis Surgical Innovations / Baxter Peri-guard cv peri-guard ocu-guard supple peri-guard peri-strips - sleeve peri-strips-strips peri-strips dry vasc General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120017 Synovis Surgical Innovations Peri-strips General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120018 Synovis Surgical Innovations / Baxter Supple peri-guard pericardium General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120019 Synovis Surgical Innovations / Baxter Peri-guard pericardium General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120020 Synovis Surgical Innovations / Baxter Supple peri-guard pericardium General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120021 Boston Scientific Corporation Lite pelvic floor repair kits Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates for Uphold LITE Other
DUET LITE Other
Posterior LITE Other
Anterior LITE Other
PS120022 Boston Scientific Corporation Pelvic floor repair system (pinnacle duet) Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates-Duet Other
PS120023 Boston Scientific Corporation Pinnacle pelvic floor repair kit ii (uphold) Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates-Uphold Other
PS120024 Boston Scientific Corporation Pinnacle pelvic floor repair kits (pinnacle) Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates-Anterior Other
Posterior Other
PS120025 Stellen Medical Brennen medical surgical mesh glucamesh/glucatex General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120026 Stellen Medical Dermmatrix surgical mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120027 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120028 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120029 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120030 C.R. Bard Inc. Bard prolapse repair system General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120031 C.R. Bard Inc. Bard pelvisoft acellular collagen biomesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120032 Caldera Medical Inc. Popmesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates-PoP Mesh Other
PS120033 Caldera Medical Inc. Ascend blue ac mesh; Ascend blue pc mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120034 Caldera Medical Inc. Ascend blue ac mesh; Ascend blue pc mesh Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120035 Coloplast Corp Exair anterior and posterior prolapse repair systems Obstetrics/
Gynecology		 01/03/2012 POP AE and Effectiveness rates, registry Other
PS120036 Coloplast Corp Exair anterior and posterior prolapse repair systems Obstetrics/
Gynecology		 01/03/2012 POP AE and Effectiveness rates, registry Consolidated
PS120037 Coloplast Corp Mentor novasilk mesh Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120038 Coloplast Corp Restorelle polypropylene mesh; Restorelle polypropylene mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
Restorelle P, EZA, EZP, and L models Other
PS120039 Cook Biotech Inc. Surgisis staple line reinforcement General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120040 Cousin Biotech SARL Biotech SAS for Biomesh® Pl and Biomesh® Plug and Patch General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120041 CryoLife, Inc. Propatch soft tissue repair matrix General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120042 CryoLife, Inc. Propatch soft tissue repair matrix General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120043 Ethicon, Inc. Gynecare prolift +m* pelvic floor repair systems Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120044 Ethicon, Inc. Gynecare prosima pelvic floor repair systems Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120045 Ethicon, Inc. Tbd ethicon mesh (gynecare gynemesh m) General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120046 Ethicon, Inc. Gynemesh prolene soft (polypropylene) nonabsorbable synthetic surgical mesh for pelvic floor repair Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120047 PFM Medical Timesh also known as timesh-tc models 6000001 & 6000004 General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120048 DSM Biomedical Bioblanket surgical mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120049 DSM Biomedical Bioblanket surgical mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120050 DSM Biomedical Medeor matrix models 30010-xx (hydrated); 30020-xx (dry) General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120051 DSM Biomedical Kensey nash ecm surgical patch General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120052 Cytori Therapeutics, Inc. Macropore surgiwrap (ts) General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120053 Herniamesh SRL Pelvimesh / hermesh 7 General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120055 Coloplast Corp Minimesh polypropylene mesh Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
Restorelle P, EZA and L model Other
PS120056 Coloplast Corp Minimesh polypropylene mesh Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
Restorelle P, EZA and L models Other
PS120057 Neomedic International SURELIFT PROLAPSE SYSTEM Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120058 Organogenesis, Inc. FORTAFLEX SURGICAL MESH General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120059 Organogenesis, Inc. FORTAFLEX SURGICAL MESH General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120060 Organogenesis, Inc. FORTAFLEX SURGICAL MESH General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120061 Smith & Nephew, Inc Immix plastifilm General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120062 Smith & Nephew Immix thin film models: Pss-004-s pss-004-sp pss-004-m pss-004-mp pss-004-l pss-004-lp General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120063 Synovis Surgical Innovation Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120064 Synovis Surgical Innovation Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120065 Synovis Surgical Innovations Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120066 Promethean Surgical Devices, Inc. Hydrocoat mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120067 Proxy Biomedical Ltd. Polyform synthetic mesh Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Terminated
PS120068 RTI Biologics, Inc. Tutopatch tutomesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120069 Shelhigh, Inc. Shelhigh porcine pericardial patch General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120070 Shelhigh, Inc. SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120071 Covidien Parietene duo and quadra polypropylene meshes Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120072 Covidien Ugytex dual knit mesh Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120073 Sofradim Production Ugytex mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120074 Sofradim Production Parietex General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120075 Covidien Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150 Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120076 Covidien Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150; Permacol surgical implant General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120077 Synovis Surgical Innovations Veritas collagen matrix General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120078 Synovis Surgical Innovations Veritas collagen matrix General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120079 Tepha, Inc. Tephaflex surgical mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120080 Tei Biosciences Inc. Tissuemend soft tissue repair matrix General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120081 Boston Scientific Xenform soft tissue repair matrix General &
Plastic Surgery		 01/03/2012 POP AE and Effectiveness rates, registry Completed
PS120082 Tei Biosciences Inc. Xenform soft tissue repair matrix Obstetrics/
Gynecology		 01/03/2012 AE and effectiveness rates Other
PS120083 W.L. Gore & Associates, Inc. Seamguard staple line reinforcement material General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120084 W.L. Gore & Associates, Inc. Modification to seamguard staple line reinforcement material General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120085 W.L. Gore & Associates, Inc. Gore bioabsorbable mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120086 W.L. Gore & Associates, Inc. Seamguard staple line reinforcement material General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Terminated
PS120087 Xylos Corporation Xylos porous surgical mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120088 Xylos Corporation Xylos porous surgical mesh General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120089 Astora Womens Health Miniarc precise single-incision sling system Gastroenterology/
Urology		 01/03/2012 SUI AE and Effectiveness rates Other
PS120090 American Medical Systems, Inc. Miniarc precise single-incision sling system Gastroenterology/
Urology		 01/03/2012 AE and effectiveness rates Other
PS120091 American Medical Systems, Inc. Miniarc precise single-incision sling system Gastroenterology/
Urology		 01/03/2012 SUI AE and Effectiveness rates Consolidated
PS120092 American Medical Systems, Inc. Miniarc precise single-incision sling system Gastroenterology/
Urology		 01/03/2012 SUI AE and Effectiveness rates Consolidated
PS120093 Boston Scientific Corporation Solyx Single Incision Sling System Gastroenterology/
Urology		 01/03/2012 SUI AE and Effectiveness rates Completed
PS120094 C.R. Bard Inc. Ajust adjustable single incision sling Gastroenterology/
Urology		 01/03/2012 AE and effectiveness rates Other
PS120095 Ethicon, Inc. Gynecare tvt secur system Gastroenterology/
Urology		 01/03/2012 AE and effectiveness rates Other
PS120096 Coloplast Corp Gyne ideas minitape rp device Gastroenterology/
Urology		 01/03/2012 AE and effectiveness rates Other
PS120097 Coloplast Corp Minitape urethral sling Gastroenterology/
Urology		 01/03/2012 AE and effectiveness rates Other
PS120098 Coloplast Corp Minitape urethral sling Gastroenterology/
Urology		 01/03/2012 AE and effectiveness rates Other
PS120099 Prosurg, Inc. Minisling adjustable polymer sling & surgical mesh with self-anchoring system (easy lift prolapse repair & minisling) General &
Plastic Surgery		 01/03/2012 AE and effectiveness rates Other
PS120100 IBI Israel Biomedical Innovations EndoFast Reliant¿. General &
Plastic Surgery		 04/09/2012 AE and Effectiveness Rates Other
PS120101 IBI Israel Biomedical Innovations Endofast reliant¿. General &
Plastic Surgery		 04/09/2012 AE & Effectiveness Rates Other
PS120102 Caldera Medical Inc. Desara mini Gastroenterology/
Urology		 04/09/2012 AE & Effectiveness Rates Other
PS120103 Injectx, Inc Biosling bioabsorbable polymer sling & surgical mesh General &
Plastic Surgery		 04/09/2012 Postmarket Surveillance Study Other
PS120104 Herniamesh SRL Biosling Bioabsorbable Polymer Sling & Surgical Mesh Gastroenterology/
Urology		 04/09/2012 AE & Effectiveness Rates Terminated
PS120105 Herniamesh SRL T-sling Obstetrics/
Gynecology		 04/09/2012 AE & Effectiveness Rates Other
PS120106 Coloplast Corp. Restorelle polypropylene mesh General &
Plastic Surgery		 04/09/2012 POP AE and Effectiveness rates, registry Completed
Restorelle P, EZA, EZP, and L models Other
PS120107 Tepha, Inc. Tephaflex surgical film General &
Plastic Surgery		 04/09/2012 AE & Effectivenss Rates Terminated
PS120108 Tepha, Inc. Tephaflex composite mesh General &
Plastic Surgery		 04/09/2012 AE & Effectineness Rates Terminated
PS120109 Cook Biotech Inc. Surgisis sling Gastroenterology/
Urology		 04/09/2012 AE & Effectiveness Rates Terminated
J-PF-POST, J-SLH, J-PFV, J-PF and J-PF-ANT models Terminated
PS120110 Stryker Neurovascular Wingspan stent system and gateway pta balloon catheter Neurology 08/08/2012 Rates of Stroke and Death Completed
PS120111 St. Jude Medical, Inc. Riata, quicksite, quickflex, durata Cardiovascular 08/16/2012 Lead Externalization and Abrasion Completed
PS130001 Boston Scientific Corporation Greenfield vena cava filters Cardiovascular 02/28/2013 Greenfield PS study Completed
PS130002 Boston Scientific Corporation Vena cava filters Cardiovascular 02/28/2013 Greenfield PS study Completed
PS130005 Cook Incorporated Vena Cava Filter Cardiovascular 02/28/2013 Celect IVC Filter Completed
PS130008 Rmt Medical Technologies Ltd Vena cava filter Cardiovascular 02/28/2013 PSS Other
PS130009 Wright Medical Technology, Inc. Linked metal-backed acetabular cups Orthopedic 03/20/2013 PSS Other
PS130010 MicroPort Link metal-backed acetabular cups Orthopedic 03/20/2013 PSS Terminated
PS130011 American Medical Systems, Inc. Elevate prolapse repair systems Obstetrics/
Gynecology		 03/13/2013 AE & Effectiveness Rates Consolidated
PS130012 Coloplast Corp Mentor suspend sling General &
Plastic Surgery		 03/13/2013 PSS Other
PS130013 Herniamesh SRL Hemiamesh t-sling Gastroenterology/
Urology		 03/13/2013 PSS Terminated
PS130015 DIMA Contasure Needleless sling Gastroenterology/
Urology		 03/13/2013 AE and Effectiveness Rates Completed
PS130016 Promedon Ophira mini sling system Gastroenterology/
Urology		 03/13/2013 PSS Terminated
PS130017 American Medical Systems, Inc. Ams triangle silicone-coated sling and surgical mesh General &
Plastic Surgery		 03/13/2013 PSS Other
PS130018 American Medical Systems, Inc. Topas system General &
Plastic Surgery		 03/13/2013 PSS Other
PS130019 American Medical Systems, Inc. Pfr sling system, (part of the pelvic floor repair system) General &
Plastic Surgery		 03/13/2013 PSS Other
PS130020 Boston Scientific Corporation Surgical fabrics General &
Plastic Surgery		 03/13/2013 PSS Other
PS130021 Boston Scientific Corporation Modification to trelex mesh surgical mesh Gastroenterology/
Urology		 03/13/2013 PSS Terminated
PS130022 Boston Scientific Corporation Modification to Surgical Mesh Polymeric Gastroenterology/
Urology		 03/13/2013 PSS Terminated
PS130023 Caldera Medical Inc. T-sling Gastroenterology/
Urology		 03/13/2013 PSS Terminated
PS130024 Caldera Medical Inc. Caldera mesh General &
Plastic Surgery		 03/13/2013 PSS Other
PS130025 Caldera Medical Inc. Desara mesh sling, model cal-dsol Gastroenterology/
Urology		 03/13/2013 PSS Terminated
PS130026 Caldera Medical Inc. Desara mesh Gastroenterology/
Urology		 03/13/2013 PSS Terminated
PS130027 Caldera Medical Inc. Desara mesh Gastroenterology/
Urology		 03/13/2013 PSS Terminated
PS130028 Covidien Ivs tunneller General &
Plastic Surgery		 03/13/2013 PSS Other
PS130029 Covidien Ivs tunneller devices General &
Plastic Surgery		 03/13/2013 PSS Other
PS130030 Coloplast Corp Mentor suspend sling General &
Plastic Surgery		 03/13/2013 PSS Other
PS130031 Organogenesis, Inc. Fortaflex surgical sling General &
Plastic Surgery		 03/13/2013 PSS Other
PS130032 Organogenesis, Inc. FortaPerm surgical sling General &
Plastic Surgery		 03/13/2013 PSS Other
PS130033 Prosurg, Inc. Zippere- bioabsorbable/non-absorbable polymer sling & surgical mesh General &
Plastic Surgery		 03/13/2013 AE and Effectiveness Rates Other
PS130034 Prosurg, Inc. Surgical mesh w/anchoring system General &
Plastic Surgery		 03/13/2013 PSS Other
PS130035 TFS Surgical Tissue fixation system General &
Plastic Surgery		 05/15/2013 AE and Effectiveness Rates Other
PS130036 RTI Biologics, Inc. Tutopatch General &
Plastic Surgery		 03/13/2013 PSS Terminated
PS130037 American Medical Systems, Inc. Miniarc pro single-incision sling system Gastroenterology/
Urology		 03/13/2013 PSS Consolidated
PS130038 C.R. Bard Inc. Ajust helical adjustable single-incision sling Gastroenterology/
Urology		 03/13/2013 PSS Other
PS130039 Coloplast Corp Altis single incision sling system Gastroenterology/
Urology		 03/13/2013 AE and effectiveness rates Completed
PS130040 Cook Biotech Inc. Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts Obstetrics/
Gynecology		 06/17/2013 AE and Effectiveness Rates Other
PS130041 Halt Medical Inc. Acessa system Obstetrics/
Gynecology		 06/17/2013 Newly Enrolled Completed
(IDE) Long Term Follow-up Completed
PS130042 Baxter Healthcare Corp Vena Cava Filter Cardiovascular 07/29/2013 PSS Other
PS130043 Aesculap, Inc. Ring upm total hip replacement Orthopedic 07/29/2013 PSS Terminated
PS130044 Boston Scientific Corporation Pinnacle LITE Pelvic Floor Repair Kits - Uphold Lite Posterior and Uphold Obstetrics/
Gynecology		 07/03/2013 POP AE and Effectiveness rates, registry Completed
Posterior Lite Other
PS130045 Aesculap, Inc. Modular range of ring pros. For hip replacement Orthopedic 07/29/2013 PSS Terminated
PS130046 St. Jude Medical, Inc. Amplatzer Cardiovascular 09/13/2013 ADVANCE ASO Completed
PS130047 Herniamesh SRL T-Sling Gastroenterology/
Urology		 09/26/2013 PSS Terminated
PS140001 Argo Medical Technologies, Inc Rewalk Neurology 06/26/2014 ReWalk RWE Study Completed
PS140002 Bard Peripheral Perivascular Simon Nitinol System Cardiovascular 10/17/2014 Simon Nitinol PS Other
PS140004 Genzyme Sanofi GlucaMesh and Glucatex (Polypropylene/Polyester) Mesh General &
Plastic Surgery		 12/11/2014 PSS Other
PS150001 Preceptis Hummingbird tympanostomy tube system Ear Nose & Throat 04/23/2015 Post-market Surveillance Study (PSS) Completed
PS150002 Fujifilm Medical Systems USA, Inc. Fujifilm duodenoscopes Gastroenterology/
Urology		 10/05/2015 Human Factors Study Completed
Sampling and Culturing Study Terminated
PS150003 Olympus Medical Systems Corporation (OMSC. Duodenoscopes Gastroenterology/
Urology		 10/05/2015 Human Factors Study Completed
Sampling and Culturing Study Completed
PS150004 Pentax Medical Duodenoscopes Gastroenterology/
Urology		 10/05/2015 Human Factors Study Completed
Sampling and Culturing Study Completed
PS160003 Parker Hannifin Corporation Indego Neurology 04/15/2016 Indego Postmarket Surveillance Study Completed
PS180001 Avenu Medical, Inc. Ellipsys vascular access system Cardiovascular 06/21/2018 Postmarket Study Other
PS190002 FUJIFILM Medical Systems, U.S.A., Inc. Duodenoscope Gastroenterology/
Urology		 08/28/2019 Sampling and Culturing Completed
PS190003 Pentax of America, Inc. Duodenoscope Gastroenterology/
Urology		 08/28/2019 Human Factors Study Other
PS190004 Pentax of America, Inc. Duodenoscope Gastroenterology/
Urology		 08/28/2019 Sampling and Culturing Other
PS190006 Tandem Diabetes Co. Control-iq, algorithm Clinical Chemistry 12/13/2019 Postmarket Surveillance Study Completed
PS200002 Olympus America, Inc. Evis exera iii duodenovideoscope tjf-q190v Gastroenterology/
Urology		 01/17/2020 Human Factors Study Completed
PS200007 Outset Medical Inc. Tablo hemodialysis system Gastroenterology/
Urology		 06/12/2020 Human Factors Study Other
PS200008 Tandem Diabetes Co. Control-iq technology Clinical Chemistry 06/23/2020 Postmarket Surveillance Completed


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Food and Drug Administration
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Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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