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 |
|---|---|---|---|---|
| intensia crt-d | P060027/S066 | 11/04/2014 | Approval | |
| instensia icd | P980049/S099 | 11/04/2014 | Approval | |
| volta(1cr/2cr/ct/2ct) icd lead, protego (s/sd/t/td) icd lead,kainox vcs 60 icd leadlinox smart (s/sd/t/td/s dx) icd lead | P980023/S060 | 09/16/2014 | Review | Approval |
| celerity 2d/3d/pilot steroid-eluting lv lead, corox (-s/-l) bp steroid-eluting lv lead | P070008/S054 | 09/16/2014 | Review | Approval |
| dextrus, selox st/jt, setrox s, and tilda t/jt/r steroid-eluting pacing leads; solox slx -bp pacing lead | P950037/S138 | 09/16/2014 | 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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