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.
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Device
Name ![Sort by Device Name [A-Z]](/scripts/cdrh/images/arrow_up-black.GIF){kind=icon} ![Sort by Device Name [Z-A]](/scripts/cdrh/images/arrow_down-black.GIF){kind=icon}
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PMA
Number
|
Decision
Date
|
Review Memo |
Approval Order |
|---|---|---|---|---|
| xc202 ceramic capacitor | P980035/S153 | 06/18/2010 | Review | Approval |
| vistatron c&t series (model vsf04 v8.0, model vsf 12 v8.0, model vsf08 v8.0) | P990001/S105 | 03/13/2013 | Review | Approval |
| virtuoso ii/secura/maximo ii icds | P980016/S273 | 05/13/2011 | Review | Approval |
| vigila and volta and passive fixation bipolar steroid eluting icd leads | P980023/S046 | 02/22/2012 | Review | Approval |
| various models of lumax icd/crt-d families | P050023/S033 | 11/26/2010 | Review | Approval |
| various models of ipg's: actros, axios, cylos, dromos, kairos, philos/ii, protos, etc. | P950037/S116 | 03/18/2013 | Review | Approval |
| various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers | P950037/S105 | 10/03/2012 | Review | Approval |
| unify quadra crt-d, unify quadra assura | P030054/S223 | 08/09/2012 | Review | Approval |
| unify crt-d system | P030054/S141 | 05/07/2010 | Review | Approval |
| transvene cs/svc lead | P980050/S057 | 05/13/2011 | Review | Approval |
| transcyte human fibroblast-derived temporary skin substitute | P960007/S021 | 09/20/2011 | Review | Approval |
| tendril sts lead model 1988tc | P960013/S054 | 04/14/2010 | Review | Approval |
| tendril sts 1988tc and 2088tc | P960013/S066 | 11/01/2011 | Review | Approval |
| tendril family of leads | P960013/S068 | 09/13/2012 | Review | Approval |
| teligen, incepta, energen and punctua icd devices | P960040/S270 | 11/30/2012 | Review | Approval |
| teligen 4-site models | P960040/S198 | 11/10/2010 | Review | Approval |
| surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin | P990004/S019 | 05/17/2011 | Review | Approval |
| stratos lv/lv-t, evia and entovis hf/hf-t crt-p's | P070008/S036 | 03/18/2013 | Review | Approval |
| stratos lv/lv-t crt-p | P070008/S017 | 11/26/2010 | Review | Approval |
| stratos lv/lv-t | P070008/S019 | 04/15/2011 | Review | Approval |
| stratos lv/lv-t | P070008/S031 | 10/03/2012 | Review | Approval |
| stratos lv/lv-t | P070008/S028 | 05/04/2012 | Review | Approval |
| st jude medical, merlin psa ex3100 system | P030054/S146 | 05/03/2010 | Review | Approval |
| spectranetics laser sheath device | P960042/S031 | 04/20/2012 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S070 | 04/04/2011 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S075 | 05/07/2012 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S071 | 08/03/2011 | Review | Approval |
| senslog/dialog/regency family of pacemakers | P880006/S067 | 03/04/2011 | Review | Approval |
| secura dr/vr/maximo ii vr/dr/virtuoso ii dr/vr icds | P980016/S240 | 03/22/2011 | Review | Approval |
| secura dr/vr, virtuoso ii dr/vr, maximo ii dr/vr icds | P980016/S187 | 04/04/2011 | Review | Approval |
| restylane l and perlane l injectable gels | P040024/S039 | 01/29/2010 | Review | Approval |
| restylane injectable gel | P040024/S052 | 07/18/2011 | Review | Approval |
| reocor s / d family of external pacemakers | P950037/S084 | 05/08/2012 | Review | Approval |
| reliaty/model 3145 pacing system analyzer | P950037/S079 | 09/02/2010 | Review | Approval |
| reliaty / model 3145 family of pacing system analyzers | P950037/S088 | 04/20/2011 | Review | Approval |
| reliance 4-site defibrillator lead | P910073/S107 | 12/20/2012 | Review | Approval |
| radiesse injectable implant | P050037/S024 | 10/31/2011 | Review | Approval |
| radiesse injectable implant | P050052/S027 | 10/31/2011 | Review | Approval |
| quickflex u model 1258t lead | P030054/S130 | 05/10/2010 | Review | Approval |
| protects xt vr, protecta vr, secura vr maximo ii icd | P980016/S280 | 05/02/2012 | Review | Approval |
| protecta xt crt-d and protecta crt-d implantable cardioverter defibrillators with cardiac resynchronization; model sw009 | P010031/S171 | 03/25/2011 | Review | Approval |
| paradym vr model 8250 & dr model 8550 | P980049/S050 | 04/07/2010 | Review | Approval |
| paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 | P060027/S026 | 09/09/2010 | Review | Approval |
| paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 | P980049/S059 | 09/09/2010 | Review | Approval |
| paradym crt-d model 8750 | P060027/S015 | 04/07/2010 | Review | Approval |
| optisense model 1999 lead | P960013/S057 | 11/26/2010 | Review | Approval |
| model 4195 attain starfix lead | P060039/S021 | 11/22/2011 | Review | Approval |
| microny family of pacemakers | P970013/S034 | 03/04/2011 | Review | Approval |
| microny family of pacemakers | P970013/S038 | 04/04/2011 | Review | Approval |
| microny family of pacemakers | P970013/S044 | 05/07/2012 | Review | Approval |
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