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.
16 to 20 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
origen, inogen, and dynagen crt-d, incepta energen punctua crt-d, cognis crt-d | P010012/S405 | 12/21/2015 | Review | |
programmer software(1503.u) for ics 3000/renamic programmers | P000009/S063 | 12/21/2015 | Review | |
programmer software (1503.u) for the ics 3000/renamic programmers | P070008/S063 | 12/21/2015 | Review | |
linox smart s65,linox smart sd 65/18,linox s dx 65/15,linox s dx 65/17,protego df-1 s 65,protego df-1 sd 65/18,protego d | P980023/S072 | 12/21/2015 | Review | |
evera s dr icd, evera s vr icd, evera xt dr icd, evera xt vr icd | P980016/S548 | 10/29/2015 | 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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