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.
61 to 65 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
carelink monitor and express monitor, cardiosight reader; carelink express | P890003/S329 | 09/11/2015 | Review | |
carelink monitor models 2490g/2491ddma | P890003/S189 | 03/22/2011 | Review | Approval |
carelink monitor, cardiosight reader, carelink express monitor | P890003/S338 | 02/01/2016 | Review | |
carelink monitor,cardiosight reader,carelink express,device data management application(ddma) | P890003/S309 | 07/03/2014 | Review | Approval |
carelink programmer model 2090 and model 9790/c programmer | P890003/S260 | 09/05/2013 | 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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