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.
31 to 35 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
medtronic pcd tachyarrhythmia control system | P920015/S146 | 10/19/2015 | Review | Approval |
symbios,synergyst ipgs | P820003/S132 | 10/19/2015 | Review | Approval |
kappa 400 dr ipg,kappa 400 sr ipg | P970012/S096 | 10/19/2015 | Review | Approval |
vitatron c20 sr ipg,vitatron c60 dr ipg,vitatron t20 sr ipg,vitatron t60 dr ipg | P990001/S119 | 10/19/2015 | Review | Approval |
legend plus ipg | P930022/S017 | 10/19/2015 | 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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