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 |
|---|---|---|---|---|
| dual chamber, implantable pulse generator | P820003/S104 | 05/13/2011 | Review | Approval |
| lead tunneler model 6888 | P830060/S062 | 11/10/2010 | Review | Approval |
| medtronic carelink programmer | P850051/S074 | 05/13/2011 | Review | Approval |
| senslog/dialog/regency family of pacemakers | P880006/S067 | 03/04/2011 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S070 | 04/04/2011 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S071 | 08/03/2011 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S075 | 05/07/2012 | Review | Approval |
| affinity/integrity/victory family of pacemakers | P880086/S189 | 03/04/2011 | Review | Approval |
| affinity/integrity/victory family of pacemakers | P880086/S195 | 04/04/2011 | Review | Approval |
| accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers | P880086/S202 | 12/04/2012 | Review | Approval |
| affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S203 | 08/03/2011 | Review | Approval |
| affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S211 | 05/07/2012 | Review | Approval |
| carelink monitor & cardiosight reader | P890003/S169 | 04/04/2011 | Review | Approval |
| medtronic carelink monitor model 2490c, cardiosight reader | P890003/S177 | 03/25/2011 | Review | Approval |
| carelink home monitor model 2490c, cardiosight reader model 2020a, caelink network device | P890003/S179 | 01/09/2012 | Review | Approval |
| medtronic carelink monitor model 2490c, cardiosight reader | P890003/S181 | 11/09/2011 | Review | Approval |
| carelink monitor models 2490g/2491ddma | P890003/S189 | 03/22/2011 | Review | Approval |
| carelink ddma software and carelink monitor | P890003/S191 | 10/19/2010 | Review | Approval |
| carelink ddma software and carelink monitor | P890003/S192 | 03/22/2011 | Review | Approval |
| carelink home monitor and cardiosight monitor | P890003/S209 | 05/04/2011 | Review | Approval |
| medtronics carelink home monitor and cardiosight reader | P890003/S211 | 05/13/2011 | Review | Approval |
| medtronic carelink monitor, cardiosight reader | P890003/S214 | 05/02/2012 | Review | Approval |
| carelink device data management application (model 2491) | P890003/S247 | 06/04/2012 | Review | Approval |
| ddma software | P890003/S251 | 09/12/2012 | Review | Approval |
| device carelink encore 29901 programmer including accessories and reveal dx, reveal xt (model sw007 v8.0) | P890003/S254 | 03/13/2013 | Review | Approval |
| ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar | P900061/S098 | 05/13/2011 | Review | Approval |
| endotak reliance 4-site leads and accessories | P910073/S077 | 11/10/2010 | Review | Approval |
| endotak reliance is-i passive fixation | P910073/S091 | 01/05/2012 | Review | Approval |
| reliance 4-site defibrillator lead | P910073/S107 | 12/20/2012 | Review | Approval |
| latitude wave communicator (model 6498) | P910077/S119 | 01/28/2013 | Review | Approval |
| cadence family of icds | P910023/S215 | 01/29/2010 | Review | Approval |
| fortify dr / vr icd systems | P910023/S226 | 05/07/2010 | Review | Approval |
| cadence family of icds | P910023/S236 | 03/04/2011 | Review | Approval |
| cadence family of icds | P910023/S254 | 04/04/2011 | Review | Approval |
| cadence/current/fortify families of icds | P910023/S257 | 06/21/2011 | Review | Approval |
| atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds | P910023/S263 | 12/04/2012 | Review | Approval |
| cadence family of icds | P910023/S264 | 08/03/2011 | Review | Approval |
| cadence family of icds | P910023/S270 | 03/09/2012 | Review | Approval |
| cadence/ellipse/fortify assura family of icds | P910023/S279 | 05/07/2012 | Review | Approval |
| icd family of devices & fortify family of devices | P910023/S295 | 08/09/2012 | Review | Approval |
| merlin home 6.1m | P910023/S307 | 12/19/2012 | Review | Approval |
| medtronic sprint quattro secure lead model 6947m | P920015/S055 | 01/09/2012 | Review | Approval |
| legend plus family of pacemakers | P930022/S012 | 05/13/2011 | Review | Approval |
| durata family of leads | P950022/S069 | 01/24/2011 | Review | Approval |
| evia / entovis & various other pulse generators | P950037/S072 | 05/07/2010 | Review | Approval |
| reliaty/model 3145 pacing system analyzer | P950037/S079 | 09/02/2010 | Review | Approval |
| evia/entovis dr/dr-t/sr-t & various other models of pulse generators | P950037/S083 | 11/26/2010 | Review | Approval |
| reocor s / d family of external pacemakers | P950037/S084 | 05/08/2012 | Review | Approval |
| reliaty / model 3145 family of pacing system analyzers | P950037/S088 | 04/20/2011 | Review | Approval |
| implantable pacemaker pulse generator,pacemaker programming | P950037/S089 | 04/15/2011 | Review | Approval |
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