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 |
|---|---|---|---|---|
| cameron health subcutaneous implantable defibrillator s-icd system | P110042/S002 | 03/07/2013 | Review | Approval |
| medtronic attain ability straight model 4396 left ventricular lead | P080006/S004 | 03/31/2011 | Review | Approval |
| medtronic attain ability plus model 4296 lead | P080006/S002 | 04/01/2011 | 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 | P070008/S031 | 10/03/2012 | Review | Approval |
| stratos lv/lv-t | P070008/S028 | 05/04/2012 | Review | Approval |
| corox otw-l bp leads | P070008/S026 | 09/30/2011 | Review | Approval |
| stratos lv/lv-t | P070008/S019 | 04/15/2011 | Review | Approval |
| stratos lv/lv-t crt-p | P070008/S017 | 11/26/2010 | Review | Approval |
| corox otw-l bp left ventricular pacing lead | P070008/S015 | 12/23/2010 | Review | Approval |
| evia/entovis pulse generators | P070008/S011 | 05/07/2010 | Review | Approval |
| paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 | P060027/S026 | 09/09/2010 | Review | Approval |
| model 4195 attain starfix lead | P060039/S021 | 11/22/2011 | Review | Approval |
| paradym crt-d model 8750 | P060027/S015 | 04/07/2010 | Review | Approval |
| ilesto 7/ 5 vr-t icd, iforia 7/ 5 vr-t icd, ilesto 7/ 5 vr-t dx icd, ilforia 7/ 5 vr-t dx icd, ilesto 7/ 5 dr-t icd | P050023/S058 | 03/18/2013 | Review | Approval |
| kronos lv-t crt-d and lumax 300/340 & 500/540 crt-d's & icd's | P050023/S053 | 10/03/2012 | 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/S048 | 05/04/2012 | Review | Approval |
| lumax 500/540 icds thoracic impedance | P050023/S047 | 11/17/2011 | 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/S039 | 04/15/2011 | Review | Approval |
| various models of lumax icd/crt-d families | P050023/S033 | 11/26/2010 | Review | Approval |
| radiesse injectable implant | P050052/S027 | 10/31/2011 | Review | Approval |
| radiesse injectable implant | P050037/S024 | 10/31/2011 | Review | Approval |
| kronos lv-t and lumax 300/340 & 500/540 hf/hf-t | P050023/S024 | 05/07/2010 | Review | Approval |
| cellpaker plasma collection device | P050044/S019 | 01/31/2012 | Review | Approval |
| juvederm ultra xc and juvederm ultra plus xc | P050047/S005 | 01/07/2010 | 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 |
| merlin net 6.1m | P030054/S237 | 12/19/2012 | Review | Approval |
| unify quadra crt-d, unify quadra assura | P030054/S223 | 08/09/2012 | Review | Approval |
| epic hf/atlas+hf/quadra assura/unify assura family of crt-ds | P030054/S206 | 05/07/2012 | Review | Approval |
| epic hf/atlas + hf family | P030054/S196 | 03/09/2012 | Review | Approval |
| epic hf/atlas + hf family of crt-ds | P030054/S189 | 08/03/2011 | Review | Approval |
| atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds | P030054/S188 | 12/04/2012 | Review | Approval |
| epic hf/atlas+hf/promote/unify families of crt-ds | P030054/S181 | 06/21/2011 | Review | Approval |
| epic hf/atlas+hf hamily of crt-ds | P030054/S177 | 04/04/2011 | Review | Approval |
| cardiac resynchronization therapy defibrillator (crt-d) | P030054/S173 | 11/29/2011 | Review | Approval |
| epic hr/atlas + hf family of crt-ds | P030054/S153 | 03/04/2011 | Review | Approval |
| st jude medical, merlin psa ex3100 system | P030054/S146 | 05/03/2010 | Review | Approval |
| unify crt-d system | P030054/S141 | 05/07/2010 | Review | Approval |
| epic hf crt-d system | P030054/S131 | 01/29/2010 | Review | Approval |
| quickflex u model 1258t lead | P030054/S130 | 05/10/2010 | Review | Approval |
| frontier/frontier ii/anthem family of crt-ps | P030035/S089 | 05/07/2012 | Review | Approval |
| cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 | P030005/S088 | 03/12/2013 | Review | Approval |
| frontier/frontierii/anthem family of crt-ps | P030035/S083 | 08/03/2011 | Review | Approval |
| anthem, frontier ii crt-ps | P030035/S082 | 12/04/2012 | Review | Approval |
| invive v172, v173 | P030005/S079 | 05/01/2012 | Review | Approval |
| frontier/frontier ii family of crt-ps | P030035/S075 | 04/04/2011 | Review | Approval |
| frontier/frontier 2 family of crt-ps | P030035/S070 | 03/04/2011 | Review | Approval |
| medtronic selectsecure lead model 3830 | P030036/S004 | 03/30/2011 | Review | Approval |
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