Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
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As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes. Links to all available summary review memos can be found here.
201 to 250 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
synergyst ii pacing system | P890003/S265 | 05/30/2013 | Review | Approval |
versatrax pacing system | P820003/S117 | 05/30/2013 | Review | Approval |
ellipse/fortify assura family of icds | P910023/S309 | 06/06/2013 | Review | Approval |
quadra assura/unify assura family of crt-ds | P030054/S238 | 06/06/2013 | Review | Approval |
affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S229 | 06/06/2013 | Review | Approval |
frontier/frontier ii/anthem family of crt-ps | P030035/S107 | 06/06/2013 | Review | Approval |
sensolog/dialog/regency family of pacemakers | P880006/S084 | 06/06/2013 | Review | Approval |
microny family pacemakers | P970013/S054 | 06/06/2013 | Review | Approval |
spectranetics laser sheath | P960042/S043 | 06/14/2013 | Review | Approval |
reply/esprit sr and dr model pacemakers | P950029/S079 | 06/20/2013 | Review | Approval |
subcutaneous implantable defibrillator (s-icd) system | P110042/S009 | 08/28/2013 | Review | Approval |
carelink programmer model 2090 and model 9790/c programmer | P890003/S260 | 09/05/2013 | Review | Approval |
fineline ii sterox lead | P960004/S060 | 09/09/2013 | Review | Approval |
mycarelink patient monitor | P890003/S280 | 09/27/2013 | Review | Approval |
entrust,intrinsic 30,intrinsic,marquis dr,marquis vr,maximo dr,maximo vr icds | P980016/S425 | 09/27/2013 | Review | Approval |
adapta,versa,sensia,advisa dr,advisa dr mri,enpulse e1,enpulse e2,enrhythm,kappa d(kappa 700),kappa d (kappa 900) ipg, k | P980035/S338 | 09/27/2013 | Review | Approval |
consulta crt-p,syncra crt-p | P010015/S208 | 09/27/2013 | Review | Approval |
insync ii protect, insync iii marquis,insync marquis, insync maximo icds | P010031/S386 | 09/27/2013 | Review | Approval |
revo mri ipg | P090013/S107 | 09/27/2013 | Review | Approval |
vitagel surgical hemostat | P050044/S021 | 10/11/2013 | Review | |
mycarelink patient monitor, device data management application, application software | P890003/S285 | 02/14/2014 | Review | Approval |
entrust icd, intrinsic 30icd, marquis dr icd, vr icd, maximo dr icd, vr icd, evera s dr icd, s vr icd,xt vr icd, maximo | P980016/S436 | 02/14/2014 | Review | Approval |
adapta, versa, sensia ipg, advisa dr ipg, dr mri ipg, enpulse el ipg, e2 ipg, enrhythm ipg, kappa d ipg | P980035/S343 | 02/14/2014 | Review | Approval |
consulta crt-p, syncra crt-p | P010015/S215 | 02/14/2014 | Review | Approval |
insync ii protect icd, iiimarquis icd, marquis icd, maximo icd, brava crt-d, concerto icd, ii crt-d, consulta icd, maxim | P010031/S397 | 02/14/2014 | Review | Approval |
revo mri ipg | P090013/S112 | 02/14/2014 | Review | Approval |
capsure sense lead | P830061/S086 | 02/18/2014 | Review | Approval |
ellipse/fortify assura family of icds | P910023/S323 | 02/26/2014 | Review | Approval |
quadra assura/unify assura family pf crt-ds | P030054/S254 | 02/26/2014 | Review | Approval |
frontier/frontier ii/ anthem family of crt-ps | P030035/S115 | 02/26/2014 | Review | Approval |
microny family of pacemakers | P970013/S057 | 02/26/2014 | Review | Approval |
affinity/ integrity/ victory/ zephyr/accent family of pacemakers | P880086/S237 | 02/26/2014 | Review | Approval |
sensolog/dialog/ regency family of pacemakers | P880006/S087 | 02/26/2014 | Review | Approval |
brava crt-d,viva s crt-d,viva xt crt-d,viva/brava/evera programmer application software | P010031/S413 | 02/27/2014 | Review | Approval |
evera s dr icd,evera s vr icd, evera xt dr icd,evera xt vr icd, viva/brava/evera programmer application software | P980016/S451 | 02/27/2014 | Review | Approval |
mycarelink monitor, | P890003/S295 | 02/27/2014 | Review | Approval |
paradym rf:models vr 9250, dr 9550, crt-d 9750; paradym models vr 8250, dr 8550, crt-d 8750 | P060027/S053 | 03/06/2014 | Review | Approval |
lattitude consult system | P910077/S138 | 03/20/2014 | Review | Approval |
epic hf/atlas + hf/quandra assura/unify assura family of crt-d's | P030054/S226 | 04/10/2014 | Review | Approval |
cadence/ellipse/fortify assura family of icd's | P910023/S297 | 04/10/2014 | Review | Approval |
affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S220 | 04/10/2014 | Review | Approval |
frontier/ frontier ii /anthem family of crt-p's | P030035/S098 | 04/10/2014 | Review | Approval |
sensolog/ dialog/regency family of pacemakers | P880006/S081 | 04/10/2014 | Review | Approval |
microny family of pacemakers | P970013/S050 | 04/10/2014 | Review | Approval |
dynagen el & mini icd's; inogen el & mini icd's; origen el & mini icd's; teligen icd | P960040/S306 | 04/11/2014 | Review | Approval |
dynagen & dynagen x4 crt-d's; inogen & inogen x4 crt-d's; origen & origen x4 crt-d's; cognis crt-d | P010012/S341 | 04/11/2014 | Review | Approval |
model 3140 zoom wireless transmitter and model 3120 zoom latitude programmer/recorder/monitor (prm) | P910077/S139 | 04/11/2014 | Review | Approval |
entovis promri pacemaker system | P950037/S132 | 05/04/2014 | Review | Approval |
ilesto icd's and crt-d's | P050023/S074 | 05/04/2014 | Review | Approval |
evia crt-p's | P070008/S050 | 05/04/2014 | Review | Approval |
Other Databases
- 510(k)s
- De Novo
- Medical Device Reports (MAUDE)
- CDRH Export Certificate Validation (CECV)
- CDRH FOIA Electronic Reading Room
- CFR Title 21
- CLIA
- Device Classification
- FDA Guidance Documents
- Humanitarian Device Exemption
- Medsun Reports
- Premarket Approvals (PMAs)
- Post-Approval Studies
- Postmarket Surveillance Studies
- Radiation-Emitting Products
- Radiation-Emitting Electronic Products Corrective Actions
- Recalls
- Registration & Listing
- Standards
- Total Product Life Cycle
- X-Ray Assembler
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