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 |
|---|---|---|---|---|
| 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 |
| carelink home monitor and cardiosight monitor | P890003/S209 | 05/04/2011 | Review | Approval |
| reliaty / model 3145 family of pacing system analyzers | P950037/S088 | 04/20/2011 | Review | Approval |
| lifevest wearable defibrillator | P010030/S023 | 04/19/2011 | 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 |
| implantable cv defibrillator/pacemaker programmer/icd monitoring system | P000009/S042 | 04/15/2011 | 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 |
| 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 selectsecure lead model 3830 | P030036/S004 | 03/30/2011 | 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 |
| consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization | P010015/S084 | 03/22/2011 | Review | Approval |
| insync crt-p & insync iii crt-p | P010015/S086 | 03/22/2011 | Review | Approval |
| concerto ii/consulta/maximo ii crt-ds | P010031/S198 | 03/22/2011 | Review | Approval |
| carelink monitor models 2490g/2491ddma | P890003/S189 | 03/22/2011 | Review | Approval |
| carelink ddma software and carelink monitor | P890003/S192 | 03/22/2011 | Review | Approval |
| kappa 400 dr/sr ipg | P970012/S068 | 03/22/2011 | Review | Approval |
| secura dr/vr/maximo ii vr/dr/virtuoso ii dr/vr icds | P980016/S240 | 03/22/2011 | Review | Approval |
| kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/senia ipgs | P980035/S168 | 03/22/2011 | Review | Approval |
| dema ipg/c & t series ipgs | P990001/S068 | 03/22/2011 | Review | Approval |
| frontier/frontier 2 family of crt-ps | P030035/S070 | 03/04/2011 | Review | Approval |
| epic hr/atlas + hf family of crt-ds | P030054/S153 | 03/04/2011 | Review | Approval |
| senslog/dialog/regency family of pacemakers | P880006/S067 | 03/04/2011 | Review | Approval |
| affinity/integrity/victory family of pacemakers | P880086/S189 | 03/04/2011 | Review | Approval |
| cadence family of icds | P910023/S236 | 03/04/2011 | Review | Approval |
| microny family of pacemakers | P970013/S034 | 03/04/2011 | Review | Approval |
| durata family of leads | P950022/S069 | 01/24/2011 | Review | Approval |
| corox otw-l bp left ventricular pacing lead | P070008/S015 | 12/23/2010 | Review | Approval |
| medtronics adapta, versa, sensia and relia implantable pulse generator | P980035/S150 | 12/08/2010 | Review | Approval |
| belos/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds | P000009/S040 | 11/26/2010 | Review | Approval |
| various models of lumax icd/crt-d families | P050023/S033 | 11/26/2010 | Review | Approval |
| stratos lv/lv-t crt-p | P070008/S017 | 11/26/2010 | Review | Approval |
| evia/entovis dr/dr-t/sr-t & various other models of pulse generators | P950037/S083 | 11/26/2010 | Review | Approval |
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