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 |
|---|---|---|---|---|
| lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds | P000009/S046 | 09/30/2011 | 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 |
| corox otw-l bp leads | P070008/S026 | 09/30/2011 | Review | Approval |
| evia/entovis/estella/effecta/ecuro | P950037/S098 | 09/30/2011 | Review | Approval |
| radiesse injectable implant | P050037/S024 | 10/31/2011 | Review | Approval |
| radiesse injectable implant | P050052/S027 | 10/31/2011 | Review | Approval |
| tendril sts 1988tc and 2088tc | P960013/S066 | 11/01/2011 | Review | Approval |
| medtronic protecta xt crt-d d314trm and protecta crt-d d334 implantable cardioverter defibrillators | P010031/S178 | 11/09/2011 | Review | Approval |
| medtronic carelink monitor model 2490c, cardiosight reader | P890003/S181 | 11/09/2011 | Review | Approval |
| medtronic protecta xt dr d314drm, protecta dr d334drm, cardioverter defibrillators | P980016/S218 | 11/09/2011 | Review | Approval |
| incepta, energen, punctua and cognis crt-d | P010012/S255 | 11/17/2011 | Review | Approval |
| lumax 500/540 icds thoracic impedance | P050023/S047 | 11/17/2011 | Review | Approval |
| incepta, energen, punctua and teligen icds | P960040/S235 | 11/17/2011 | Review | Approval |
| model 4195 attain starfix lead | P060039/S021 | 11/22/2011 | Review | Approval |
| cardiac resynchronization therapy defibrillator (crt-d) | P030054/S173 | 11/29/2011 | Review | Approval |
| endotak reliance is-i passive fixation | P910073/S091 | 01/05/2012 | Review | Approval |
| medtronic consulta crt-d d204trm, maximo ii crt-d d264trm implantable cardioverter defibrillators | P010031/S176 | 01/09/2012 | Review | Approval |
| carelink home monitor model 2490c, cardiosight reader model 2020a, caelink network device | P890003/S179 | 01/09/2012 | Review | Approval |
| medtronic sprint quattro secure lead model 6947m | P920015/S055 | 01/09/2012 | Review | Approval |
| medtronic secura dr d204drm, maximo ii d264drm, implantable cardioverter defibrillators | P980016/S216 | 01/09/2012 | Review | Approval |
| cellpaker plasma collection device | P050044/S019 | 01/31/2012 | Review | Approval |
| vigila and volta and passive fixation bipolar steroid eluting icd leads | P980023/S046 | 02/22/2012 | Review | Approval |
| epic hf/atlas + hf family | P030054/S196 | 03/09/2012 | Review | Approval |
| cadence family of icds | P910023/S270 | 03/09/2012 | Review | Approval |
| spectranetics laser sheath device | P960042/S031 | 04/20/2012 | Review | Approval |
| invive v172, v173 | P030005/S079 | 05/01/2012 | Review | Approval |
| medtronic carelink monitor, cardiosight reader | P890003/S214 | 05/02/2012 | Review | Approval |
| protects xt vr, protecta vr, secura vr maximo ii icd | P980016/S280 | 05/02/2012 | Review | Approval |
| belos dr/dr-t/vr/vr-t/lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t/xelos dr-t | P000009/S047 | 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/S048 | 05/04/2012 | Review | Approval |
| stratos lv/lv-t | P070008/S028 | 05/04/2012 | Review | Approval |
| cylos/dr/dr-t/vr/dromos dr/sr/sl/kairos dr/sr/sl/d/s/philos/dr/dr-t/sr/slr/d/s/philos ii d/dr/s/slr/sr/dr-t/protos dr/cl | P950037/S100 | 05/04/2012 | Review | Approval |
| epic hf/atlas+hf/quadra assura/unify assura family of crt-ds | P030054/S206 | 05/07/2012 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S075 | 05/07/2012 | Review | Approval |
| affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S211 | 05/07/2012 | Review | Approval |
| cadence/ellipse/fortify assura family of icds | P910023/S279 | 05/07/2012 | Review | Approval |
| microny family of pacemakers | P970013/S044 | 05/07/2012 | Review | Approval |
| frontier/frontier ii/anthem family of crt-ps | P030035/S089 | 05/07/2012 | Review | Approval |
| reocor s / d family of external pacemakers | P950037/S084 | 05/08/2012 | Review | Approval |
| consulta crt-p, syncra crt-p | P010015/S157 | 06/04/2012 | Review | Approval |
| concert ii, consulta, & maximo ii crt-ds | P010031/S296 | 06/04/2012 | Review | Approval |
| carelink device data management application (model 2491) | P890003/S247 | 06/04/2012 | Review | Approval |
| maximo ii, secura & virtuoso ii dr/vr icds | P980016/S343 | 06/04/2012 | Review | Approval |
| advisa dr ipg | P980035/S264 | 06/04/2012 | Review | Approval |
| unify quadra crt-d, unify quadra assura | P030054/S223 | 08/09/2012 | Review | Approval |
| icd family of devices & fortify family of devices | P910023/S295 | 08/09/2012 | Review | Approval |
| ddma software | P890003/S251 | 09/12/2012 | Review | Approval |
| maximo ii df4 icd, secura df4 icd | P980016/S362 | 09/12/2012 | Review | Approval |
| tendril family of leads | P960013/S068 | 09/13/2012 | Review | Approval |
| belos dr/dr-t/vr/vr-t, lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's | P000009/S049 | 10/03/2012 | Review | Approval |
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