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
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Decision
Date
|
Review Memo |
Approval Order |
|---|---|---|---|---|
| affinity/ integrity/ victory/ zephyr/accent family of pacemakers | P880086/S237 | 02/26/2014 | Review | Approval |
| affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S229 | 06/06/2013 | 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/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/S093 | 08/27/2015 | Review | |
| sensolog/ dialog/regency family of pacemakers | P880006/S089 | 09/12/2014 | Review | Approval |
| sensolog/dialog/ regency family of pacemakers | P880006/S087 | 02/26/2014 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S084 | 06/06/2013 | Review | Approval |
| integrity afx dr model 5346 dual chamber pulse generator and programmer software model 3307, v2.2a | P880086/S083 | 07/11/2001 | Approval | |
| sensolog/ dialog/regency family of pacemakers | P880006/S081 | 04/10/2014 | 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 |
| 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 |
| medtronic carelink programmer | P850051/S074 | 05/13/2011 | Review | Approval |
| capsure sense lead | P830061/S086 | 02/18/2014 | Review | Approval |
| lead tunneler model 6888 | P830060/S062 | 11/10/2010 | Review | Approval |
| symbios,synergyst ipgs | P820003/S132 | 10/19/2015 | Review | Approval |
| versatrax pacing system | P820003/S117 | 05/30/2013 | Review | Approval |
| dual chamber, implantable pulse generator | P820003/S104 | 05/13/2011 | Review | Approval |
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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