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.
86 to 90 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
insync crt-p/insync iii crt-p | P010015/S107 | 05/13/2011 | Review | Approval |
dual chamber, implantable pulse generator | P820003/S104 | 05/13/2011 | Review | Approval |
dema ipg/c & t series ipgs | P990001/S082 | 05/13/2011 | Review | Approval |
ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar | P900061/S098 | 05/13/2011 | Review | Approval |
transvene cs/svc lead | P980050/S057 | 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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