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
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PMA
Number
|
Decision
Date
|
Review Memo |
Approval Order |
|---|---|---|---|---|
| legend plus family of pacemakers | P930022/S012 | 05/13/2011 | Review | Approval |
| lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds | P000009/S046 | 09/30/2011 | Review | Approval |
| lifevest waerable defibrillator | P010030/S031 | 11/02/2012 | Review | Approval |
| lifevest wearable defibrillator | P010030/S023 | 04/19/2011 | Review | Approval |
| linox smart steroid-eluting dual-coil icd leads | P980023/S038 | 09/17/2010 | Review | Approval |
| lumax 300/340 vr-t/dr-t/hf-t/lumax 500/540 vr-t/dr-t/hf-t/lumax 540 vr-t dx | P050023/S046 | 09/30/2011 | Review | Approval |
| lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t | P050023/S048 | 05/04/2012 | Review | Approval |
| lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t | P050023/S039 | 04/15/2011 | Review | Approval |
| lumax 500/540 icds thoracic impedance | P050023/S047 | 11/17/2011 | Review | Approval |
| maximo ii df4 icd, secura df4 icd | P980016/S362 | 09/12/2012 | Review | Approval |
| maximo ii, secura & virtuoso ii dr/vr icds | P980016/S343 | 06/04/2012 | Review | Approval |
| medtronic attain ability plus model 4296 lead | P080006/S002 | 04/01/2011 | Review | Approval |
| medtronic attain ability straight model 4396 left ventricular lead | P080006/S004 | 03/31/2011 | Review | Approval |
| medtronic carelink monitor model 2490c, cardiosight reader | P890003/S181 | 11/09/2011 | Review | Approval |
| medtronic carelink monitor model 2490c, cardiosight reader | P890003/S177 | 03/25/2011 | Review | Approval |
| medtronic carelink monitor, cardiosight reader | P890003/S214 | 05/02/2012 | Review | Approval |
| medtronic carelink programmer | P850051/S074 | 05/13/2011 | Review | Approval |
| medtronic consulta crt-d d204trm, maximo ii crt-d d264trm implantable cardioverter defibrillators | P010031/S176 | 01/09/2012 | Review | Approval |
| medtronic protecta xt crt-d d314trm and protecta crt-d d334 implantable cardioverter defibrillators | P010031/S178 | 11/09/2011 | Review | Approval |
| medtronic protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, implantable cardioverter defibrillators | P980016/S211 | 03/25/2011 | Review | Approval |
| medtronic protecta xt dr d314drm, protecta dr d334drm, cardioverter defibrillators | P980016/S218 | 11/09/2011 | Review | Approval |
| medtronic secura dr d204drm, maximo ii d264drm, implantable cardioverter defibrillators | P980016/S216 | 01/09/2012 | Review | Approval |
| medtronic selectsecure lead model 3830 | P030036/S004 | 03/30/2011 | Review | Approval |
| medtronic sprint quattro secure lead model 6947m | P920015/S055 | 01/09/2012 | Review | Approval |
| medtronics adapta, versa, sensia and relia implantable pulse generator | P980035/S150 | 12/08/2010 | Review | Approval |
| medtronics carelink home monitor and cardiosight reader | P890003/S211 | 05/13/2011 | Review | Approval |
| merlin home 6.1m | P910023/S307 | 12/19/2012 | Review | Approval |
| merlin net 6.1m | P030054/S237 | 12/19/2012 | Review | Approval |
| microny family of pacemakers | P970013/S040 | 08/03/2011 | Review | Approval |
| microny family of pacemakers | P970013/S044 | 05/07/2012 | Review | Approval |
| microny family of pacemakers | P970013/S038 | 04/04/2011 | Review | Approval |
| microny family of pacemakers | P970013/S034 | 03/04/2011 | Review | Approval |
| model 4195 attain starfix lead | P060039/S021 | 11/22/2011 | Review | Approval |
| optisense model 1999 lead | P960013/S057 | 11/26/2010 | Review | Approval |
| paradym crt-d model 8750 | P060027/S015 | 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 vr model 8250 & dr model 8550 | P980049/S050 | 04/07/2010 | 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 |
| protects xt vr, protecta vr, secura vr maximo ii icd | P980016/S280 | 05/02/2012 | Review | Approval |
| quickflex u model 1258t lead | P030054/S130 | 05/10/2010 | Review | Approval |
| radiesse injectable implant | P050037/S024 | 10/31/2011 | Review | Approval |
| radiesse injectable implant | P050052/S027 | 10/31/2011 | Review | Approval |
| reliance 4-site defibrillator lead | P910073/S107 | 12/20/2012 | Review | Approval |
| reliaty / model 3145 family of pacing system analyzers | P950037/S088 | 04/20/2011 | Review | Approval |
| reliaty/model 3145 pacing system analyzer | P950037/S079 | 09/02/2010 | Review | Approval |
| reocor s / d family of external pacemakers | P950037/S084 | 05/08/2012 | Review | Approval |
| restylane injectable gel | P040024/S052 | 07/18/2011 | Review | Approval |
| restylane l and perlane l injectable gels | P040024/S039 | 01/29/2010 | Review | Approval |
| secura dr/vr, virtuoso ii dr/vr, maximo ii dr/vr icds | P980016/S187 | 04/04/2011 | Review | Approval |
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