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 |
|---|---|---|---|---|
| reliance 4-site defibrillator lead | P910073/S107 | 12/20/2012 | Review | Approval |
| endotak reliance is-i passive fixation | P910073/S091 | 01/05/2012 | Review | Approval |
| endotak reliance 4-site leads and accessories | P910073/S077 | 11/10/2010 | Review | Approval |
| ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar | P900061/S098 | 05/13/2011 | 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 |
| ddma software | P890003/S251 | 09/12/2012 | Review | Approval |
| carelink device data management application (model 2491) | P890003/S247 | 06/04/2012 | Review | Approval |
| medtronic carelink monitor, cardiosight reader | P890003/S214 | 05/02/2012 | Review | Approval |
| medtronics carelink home monitor and cardiosight reader | P890003/S211 | 05/13/2011 | Review | Approval |
| carelink home monitor and cardiosight monitor | P890003/S209 | 05/04/2011 | Review | Approval |
| carelink ddma software and carelink monitor | P890003/S192 | 03/22/2011 | Review | Approval |
| carelink ddma software and carelink monitor | P890003/S191 | 10/19/2010 | Review | Approval |
| carelink monitor models 2490g/2491ddma | P890003/S189 | 03/22/2011 | Review | Approval |
| medtronic carelink monitor model 2490c, cardiosight reader | P890003/S181 | 11/09/2011 | 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/S177 | 03/25/2011 | Review | Approval |
| carelink monitor & cardiosight reader | P890003/S169 | 04/04/2011 | Review | Approval |
| affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S211 | 05/07/2012 | Review | Approval |
| affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S203 | 08/03/2011 | Review | Approval |
| accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers | P880086/S202 | 12/04/2012 | Review | Approval |
| affinity/integrity/victory family of pacemakers | P880086/S195 | 04/04/2011 | Review | Approval |
| affinity/integrity/victory family of pacemakers | P880086/S189 | 03/04/2011 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S075 | 05/07/2012 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S071 | 08/03/2011 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S070 | 04/04/2011 | Review | Approval |
| senslog/dialog/regency family of pacemakers | P880006/S067 | 03/04/2011 | Review | Approval |
| medtronic carelink programmer | P850051/S074 | 05/13/2011 | Review | Approval |
| lead tunneler model 6888 | P830060/S062 | 11/10/2010 | Review | Approval |
| dual chamber, implantable pulse generator | P820003/S104 | 05/13/2011 | Review | Approval |
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