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 |
|---|---|---|---|---|
| secura dr/vr/maximo ii vr/dr/virtuoso ii dr/vr icds | P980016/S240 | 03/22/2011 | Review | Approval |
| medtronic protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, implantable cardioverter defibrillators | P980016/S211 | 03/25/2011 | Review | Approval |
| protecta xt crt-d and protecta crt-d implantable cardioverter defibrillators with cardiac resynchronization; model sw009 | P010031/S171 | 03/25/2011 | Review | Approval |
| medtronic carelink monitor model 2490c, cardiosight reader | P890003/S177 | 03/25/2011 | Review | Approval |
| evia / entovis family of pulse generators | P950037/S091 | 03/25/2011 | Review | Approval |
| medtronic selectsecure lead model 3830 | P030036/S004 | 03/30/2011 | 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 |
| consulta crt-d/concerto ii crt-d/maximo crt-d icds | P010031/S150 | 04/04/2011 | Review | Approval |
| frontier/frontier ii family of crt-ps | P030035/S075 | 04/04/2011 | Review | Approval |
| epic hf/atlas+hf hamily of crt-ds | P030054/S177 | 04/04/2011 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S070 | 04/04/2011 | Review | Approval |
| affinity/integrity/victory family of pacemakers | P880086/S195 | 04/04/2011 | Review | Approval |
| carelink monitor & cardiosight reader | P890003/S169 | 04/04/2011 | Review | Approval |
| cadence family of icds | P910023/S254 | 04/04/2011 | Review | Approval |
| microny family of pacemakers | P970013/S038 | 04/04/2011 | Review | Approval |
| secura dr/vr, virtuoso ii dr/vr, maximo ii dr/vr icds | P980016/S187 | 04/04/2011 | Review | Approval |
| advisa dr ipg | P980035/S134 | 04/04/2011 | Review | Approval |
| implantable cv defibrillator/pacemaker programmer/icd monitoring system | P000009/S042 | 04/15/2011 | 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 |
| stratos lv/lv-t | P070008/S019 | 04/15/2011 | Review | Approval |
| implantable pacemaker pulse generator,pacemaker programming | P950037/S089 | 04/15/2011 | Review | Approval |
| lifevest wearable defibrillator | P010030/S023 | 04/19/2011 | Review | Approval |
| reliaty / model 3145 family of pacing system analyzers | P950037/S088 | 04/20/2011 | Review | Approval |
| carelink home monitor and cardiosight monitor | P890003/S209 | 05/04/2011 | Review | Approval |
| dema ipg/c & t series ipgs | P990001/S082 | 05/13/2011 | Review | Approval |
| insync crt-p/insync iii crt-p | P010015/S107 | 05/13/2011 | Review | Approval |
| concerto ii/maximo ii/consulta crt-ds | P010031/S228 | 05/13/2011 | Review | Approval |
| dual chamber, implantable pulse generator | P820003/S104 | 05/13/2011 | Review | Approval |
| medtronic carelink programmer | P850051/S074 | 05/13/2011 | Review | Approval |
| medtronics carelink home monitor and cardiosight reader | P890003/S211 | 05/13/2011 | Review | Approval |
| ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar | P900061/S098 | 05/13/2011 | Review | Approval |
| legend plus family of pacemakers | P930022/S012 | 05/13/2011 | Review | Approval |
| kappa 400 dr/sr ipgs | P970012/S081 | 05/13/2011 | Review | Approval |
| virtuoso ii/secura/maximo ii icds | P980016/S273 | 05/13/2011 | Review | Approval |
| kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/sensia ipgs | P980035/S200 | 05/13/2011 | Review | Approval |
| transvene cs/svc lead | P980050/S057 | 05/13/2011 | Review | Approval |
| surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin | P990004/S019 | 05/17/2011 | Review | Approval |
| epic hf/atlas+hf/promote/unify families of crt-ds | P030054/S181 | 06/21/2011 | Review | Approval |
| cadence/current/fortify families of icds | P910023/S257 | 06/21/2011 | Review | Approval |
| restylane injectable gel | P040024/S052 | 07/18/2011 | Review | Approval |
| frontier/frontierii/anthem family of crt-ps | P030035/S083 | 08/03/2011 | Review | Approval |
| epic hf/atlas + hf family of crt-ds | P030054/S189 | 08/03/2011 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S071 | 08/03/2011 | Review | Approval |
| affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S203 | 08/03/2011 | Review | Approval |
| cadence family of icds | P910023/S264 | 08/03/2011 | Review | Approval |
| microny family of pacemakers | P970013/S040 | 08/03/2011 | Review | Approval |
| concerto ii/consulta/insync ii marquis/iii marquis/insync maximo/sentry/maximo ii/protecta/protecta xt | P010031/S252 | 08/18/2011 | Review | Approval |
| entrust/intrinsic/marquis/maximo/ii/protecta xt/icd/secura/virtuoso ii | P980016/S298 | 08/18/2011 | Review | Approval |
| transcyte human fibroblast-derived temporary skin substitute | P960007/S021 | 09/20/2011 | Review | Approval |
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