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
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Review Memo |
Approval Order |
|---|---|---|---|---|
| affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S229 | 06/06/2013 | Review | Approval |
| frontier/frontier ii/anthem family of crt-ps | P030035/S107 | 06/06/2013 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S084 | 06/06/2013 | Review | Approval |
| versatrax pacing system | P820003/S117 | 05/30/2013 | Review | Approval |
| synergyst ii pacing system | P890003/S265 | 05/30/2013 | 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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