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 |
|---|---|---|---|---|
| carelink home monitor and cardiosight monitor | P890003/S209 | 05/04/2011 | Review | Approval |
| carelink device data management application (model 2491) | P890003/S247 | 06/04/2012 | 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 |
| cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 | P030005/S088 | 03/12/2013 | Review | Approval |
| cardiac resynchronization therapy defibrillator (crt-d) | P030054/S173 | 11/29/2011 | Review | Approval |
| cameron health subcutaneous implantable defibrillator s-icd system | P110042/S002 | 03/07/2013 | Review | Approval |
| cadence/ellipse/fortify assura family of icds | P910023/S279 | 05/07/2012 | Review | Approval |
| cadence/current/fortify families of icds | P910023/S257 | 06/21/2011 | Review | Approval |
| cadence family of icds | P910023/S254 | 04/04/2011 | Review | Approval |
| cadence family of icds | P910023/S236 | 03/04/2011 | Review | Approval |
| cadence family of icds | P910023/S215 | 01/29/2010 | Review | Approval |
| cadence family of icds | P910023/S270 | 03/09/2012 | Review | Approval |
| cadence family of icds | P910023/S264 | 08/03/2011 | Review | Approval |
| belos/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds | P000009/S040 | 11/26/2010 | 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 |
| 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 |
| belos & lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's | P000009/S051 | 03/18/2013 | Review | Approval |
| atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds | P910023/S263 | 12/04/2012 | Review | Approval |
| atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds | P030054/S188 | 12/04/2012 | Review | Approval |
| anthem, frontier ii crt-ps | P030035/S082 | 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 |
| 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 |
| advisa dr ipg | P980035/S134 | 04/04/2011 | Review | Approval |
| advisa dr ipg | P980035/S264 | 06/04/2012 | Review | Approval |
| ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar | P900061/S098 | 05/13/2011 | Review | Approval |
| accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers | P880086/S202 | 12/04/2012 | Review | Approval |
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