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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Nathan S. Ivey, PhD
Scientific Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4278
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Nathan.Ivey@fda.hhs.gov
           
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Name
Study Status
PS060003 Cardica, Inc. C-port distal anastomosis system Cardiovascular 06/14/2006 Graft Patency and Technical Failure Progress Adequate
PS090007 Globus Medical, Inc. Transition stabilization system Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Progress Inadequate
PS090008 Medtronic Cd horizon® peek rods Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Progress Inadequate
PS090011 Paradigm Spine Dss stabilization system Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Progress Inadequate
PS090015 Exactech, Inc. Modified vertiflex spinal screw system (with dynabolt rods) Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Progress Inadequate
PS090016 Zimmer Spine Zimmer® dynesys® spinal system with dto implant Orthopedic 10/05/2009 Fusion, AEs, Surg Procedures Progress Inadequate
PS100001 MicroVention, Inc. Microvention hydrocoil-soft-frame Neurology 04/15/2010 HydroSoft/HydroFrame Study Progress Adequate
PS110001 Vermillion, Inc Ova1 Immunology 01/31/2011 OVA1 Performance in Pre and Post Menopausal Women Progress Inadequate
PS110002 Nexus CMF Tmj fossa-eminence/condylar prosthesis system Dental 02/04/2011 Registry Database Plan Overdue
TMJM Registry Study - Total Plan Overdue
TMJM Registry Study - Partial Plan Overdue
PS110003 TMJ Concepts Patient-fitted tmj reconstruction prosthesis system Dental 02/04/2011 Time to Revision and Explant Analysis Progress Inadequate
PS110004 Biomet Microfixation Total temporomandibular joint replacement system Dental 02/04/2011 Time to Revision Progress Adequate
Explant Progress Adequate
PS110005 Biomet Inc. Porous titanium acetabular augments, m2a magnum 12/14 taper inserts and one¿piece modular heads,lateralized taperloc microplasty femoral,m2a magnum tri-spike acetabular component, altra press-fit hip system, echo bi¿metric press-fit stems,parallel-side Orthopedic 05/06/2011 Metal Ion Levels Progress Adequate
Explant Analysis Progress Adequate
PS110029 Encore Medical 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 Progress Inadequate
Device Retrieval Study Progress Inadequate
PS110038 Johnson and Johnson Depuy pinnacle metal-on-metal acetabular cup liners, pinnacle with gription acetabular cups, asr xl modular acetabular cup system, asr 300 acetabular cup system, asr taper sleeve adapter, c-stem amt, tri-lock bone preservation stem, corail amt dysplasi Orthopedic 05/06/2011 Metal ion levels Progress Inadequate
Explant Analysis Progress Adequate
PS110070 MicroPort Metal transcend articulation system Orthopedic 05/06/2011 Metal ion levels Progress Inadequate
PS110093 Zimmer Zweymueller-sl hip prosthesis stem Orthopedic 05/06/2011 Cross-Sectional Study Progress Inadequate
Explant Analysis Progress Inadequate
PS120001 ACell, Inc. Acell Matristem Pelvic Floor Matrix General &
Plastic Surgery
01/03/2012 POP AE and Effectiveness rates, registry Progress Adequate
PS120004 American Medical Systems, Inc. Ams elevate anterior & apical prolapse repair system with intepro llite General &
Plastic Surgery
01/03/2012 POP AE and effectiveness rates, registry Progress Adequate
PS120006 American Medical Systems, Inc. Ams elevate apical and posterior prolapse repair system with intepro lite General &
Plastic Surgery
01/03/2012 POP AE and Effectiveness rates, registry Progress Adequate
PS120035 Coloplast Corp Exair anterior and posterior prolapse repair systems General &
Plastic Surgery
01/03/2012 POP AE and Effectiveness rates, registry Progress Adequate
PS120081 Tei Biosciences Inc. Xenform soft tissue repair matrix General &
Plastic Surgery
01/03/2012 POP AE and Effectiveness rates, registry Progress Adequate
PS120089 American Medical Systems, Inc. Miniarc precise single-incision sling system General &
Plastic Surgery
01/03/2012 SUI AE and Effectiveness rates Progress Adequate
PS120093 Boston Scientific Corporation Solyx Single Incision Sling System General &
Plastic Surgery
01/03/2012 SUI AE and Effectiveness rates Progress Adequate
PS120106 Coloplast Corp. Restorelle polypropylene mesh Obstetrics/
Gynecology
04/09/2012 POP AE and Effectiveness rates, registry Progress Adequate
PS120110 Stryker Neurovascular Wingspan stent system and gateway pta balloon catheter Neurology 08/08/2012 Rates of Stroke and Death Progress Adequate
PS120111 St. Jude Medical, Inc. Riata, quicksite, quickflex, durata Cardiovascular 08/16/2012 Lead Externalization and Abrasion Progress Inadequate
PS130015 DIMA Contasure Needleless sling General &
Plastic Surgery
03/13/2013 AE and Effectiveness Rates Progress Adequate
PS130039 Coloplast Corp Altis single incision sling system Obstetrics/
Gynecology
03/13/2013 AE and effectiveness rates Study Pending
PS130041 Halt Medical Inc. Acessa system Obstetrics/
Gynecology
06/17/2013 Newly Enrolled Study Pending
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 Progress Adequate
PS130046 St. Jude Medical, Inc. Amplatzer Cardiovascular 09/30/2013 Amplatzer ASO Study Pending
PS140001 Argo Medical Technologies, Inc Rewalk Physical Medicine 06/26/2014 ReWalk Registry Plan Pending
PS140002 Bard Peripheral Perivascular Simon Nitinol System Cardiovascular 10/17/2014 PSS Plan Pending
PS140003 Mast Biosurgery USA Inc. Macropore Surgiwrap (TS) General &
Plastic Surgery
11/17/2014 PSS Plan Pending
PS140004 Genzyme Sanofi GlucaMesh and Glucatex (Polypropylene/Polyester) Mesh 12/11/2014 PSS Plan Pending
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