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.
| 71 to 75 of 325 records |
|
|
Device
Name ![Sort by Device Name [A-Z]](/scripts/cdrh/images/arrow_up-black.GIF){kind=icon} ![Sort by Device Name [Z-A]](/scripts/cdrh/images/arrow_down-black.GIF){kind=icon}
|
PMA
Number
|
Decision
Date
|
Review Memo |
Approval Order |
|---|---|---|---|---|
| viva quad xt crt-d,viva quad s crt-d,brava quad crt-d,viva quad c crt-d,viva/brava/evera software application | P010031/S442 | 07/03/2014 | Review | Approval |
| carelink monitor,cardiosight reader,carelink express,device data management application(ddma) | P890003/S309 | 07/03/2014 | Review | Approval |
| latitude nxt 2.0 patient management system | P910077/S140 | 06/20/2014 | Review | Approval |
| attain ability model 4x96 lead | P080006/S063 | 05/15/2014 | Review | Approval |
| entovis promri pacemaker system | P950037/S132 | 05/04/2014 | 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
-
