Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
-
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.
11 to 15 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
versatrax pacing system | P820003/S117 | 05/30/2013 | Review | Approval |
various models of lumax icd/crt-d families | P050023/S033 | 11/26/2010 | Review | Approval |
various models of ipg's: actros, axios, cylos, dromos, kairos, philos/ii, protos, etc. | P950037/S116 | 03/18/2013 | Review | Approval |
various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers | P950037/S105 | 10/03/2012 | Review | Approval |
unify quadra crt-d, unify quadra assura | P030054/S223 | 08/09/2012 | 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
-