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 |
|---|---|---|---|---|
| atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds | P030054/S188 | 12/04/2012 | Review | Approval |
| apligraf (graftskin) | P950032/S016 | 06/20/2000 | 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/zephyr/accent family of pacemakers | P880086/S220 | 04/10/2014 | Review | Approval |
| affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S229 | 06/06/2013 | 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 |
| affinity/integrity / victory /zephyr accent family of pacemakers | P880086/S255 | 08/27/2015 | Review | |
| affinity/ integrity/ victory/ zephyr/accent family of pacemakers | P880086/S237 | 02/26/2014 | Review | Approval |
| affinity, integrity, victory, zephyr, & accent family of pacemakers | P880086/S245 | 09/12/2014 | Review | Approval |
| advisa sr ipg | P980035/S424 | 06/22/2015 | Review | |
| advisa dr,advisa dr mri | P980035/S358 | 07/09/2014 | Review | Approval |
| advisa dr ipg | P980035/S264 | 06/04/2012 | Review | Approval |
| advisa dr ipg | P980035/S134 | 04/04/2011 | Review | Approval |
| adapta,versa,sensia,advisa dr,advisa dr mri,enpulse e1,enpulse e2,enrhythm,kappa d(kappa 700),kappa d (kappa 900) ipg, k | P980035/S338 | 09/27/2013 | Review | Approval |
| adapta,versa,sensia ipg,advisa dr ipg,advisa dr mri ipg,at500 dddrp pacing system ipg, enpulse e2 ipg,enpulse e2 ipg,kap | P980035/S404 | 10/19/2015 | Review | Approval |
| adapta, versa, sensia ipg, advisa dr ipg, dr mri ipg, enpulse el ipg, e2 ipg, enrhythm ipg, kappa d ipg | P980035/S343 | 02/14/2014 | Review | Approval |
| adapta versa, sensia ipg, advisa dr ipg, advisa dr mri ipg and enpulse e1 ipg | P980035/S311 | 05/24/2013 | Review | Approval |
| activitrax ii ipg,activitrax ipg,legend ii ipg,legend ipg,micro minix ipg,minix ipg,minix st ipg,premier ipg,prevail ipg | P850051/S082 | 10/19/2015 | 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 |
| 5086 mri capsurefix mri surescan leads | P090013/S200 | 09/11/2015 | Review | |
| 5076 capsurefix novus surescan leads | P930039/S138 | 09/11/2015 | Review |
Other Databases
- 510(k)s
- De Novo
- Medical Device Reports (MAUDE)
- CDRH Export Certificate Validation (CECV)
- CDRH FOIA Electronic Reading Room
- CFR Title 21
- CLIA
- Device Classification
- FDA Guidance Documents
- Humanitarian Device Exemption
- Medsun Reports
- Premarket Approvals (PMAs)
- Post-Approval Studies
- Postmarket Surveillance Studies
- Radiation-Emitting Products
- Radiation-Emitting Electronic Products Corrective Actions
- Recalls
- Registration & Listing
- Standards
- Total Product Life Cycle
- X-Ray Assembler
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