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 |
---|---|---|---|---|
kronos lv-t and lumax 300/340 & 500/540 hf/hf-t | P050023/S024 | 05/07/2010 | Review | Approval |
evia/entovis pulse generators | P000009/S035 | 05/07/2010 | Review | Approval |
evia/entovis pulse generators | P070008/S011 | 05/07/2010 | Review | Approval |
quickflex u model 1258t lead | P030054/S130 | 05/10/2010 | Review | Approval |
xc202 ceramic capacitor | P980035/S153 | 06/18/2010 | 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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