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.
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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}
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PMA
Number
|
Decision
Date
|
Review Memo |
Approval Order |
|---|---|---|---|---|
| carelink ddma software and carelink monitor | P890003/S191 | 10/19/2010 | Review | Approval |
| linox smart steroid-eluting dual-coil icd leads | P980023/S038 | 09/17/2010 | Review | Approval |
| paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 | P060027/S026 | 09/09/2010 | Review | Approval |
| paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 | P980049/S059 | 09/09/2010 | Review | Approval |
| reliaty/model 3145 pacing system analyzer | P950037/S079 | 09/02/2010 | Review | Approval |
| xc202 ceramic capacitor | P980035/S153 | 06/18/2010 | Review | Approval |
| quickflex u model 1258t lead | P030054/S130 | 05/10/2010 | Review | Approval |
| fortify dr / vr icd systems | P910023/S226 | 05/07/2010 | Review | Approval |
| unify crt-d system | P030054/S141 | 05/07/2010 | Review | Approval |
| evia / entovis & various other pulse generators | P950037/S072 | 05/07/2010 | Review | Approval |
| evia/entovis pulse generators | P000009/S035 | 05/07/2010 | Review | Approval |
| kronos lv-t and lumax 300/340 & 500/540 hf/hf-t | P050023/S024 | 05/07/2010 | Review | Approval |
| evia/entovis pulse generators | P070008/S011 | 05/07/2010 | Review | Approval |
| st jude medical, merlin psa ex3100 system | P030054/S146 | 05/03/2010 | Review | Approval |
| tendril sts lead model 1988tc | P960013/S054 | 04/14/2010 | Review | Approval |
| paradym vr model 8250 & dr model 8550 | P980049/S050 | 04/07/2010 | Review | Approval |
| paradym crt-d model 8750 | P060027/S015 | 04/07/2010 | Review | Approval |
| cadence family of icds | P910023/S215 | 01/29/2010 | Review | Approval |
| epic hf crt-d system | P030054/S131 | 01/29/2010 | Review | Approval |
| restylane l and perlane l injectable gels | P040024/S039 | 01/29/2010 | Review | Approval |
| juvederm ultra xc and juvederm ultra plus xc | P050047/S005 | 01/07/2010 | Review | Approval |
| floseal hemostatic matrix 5 ml/10 ml kit | P990009/S025 | 01/07/2010 | Review | Approval |
| home monitoring system | P950037/S019 | 10/11/2001 | Approval | |
| integrity afx dr model 5346 dual chamber pulse generator and programmer software model 3307, v2.2a | P880086/S083 | 07/11/2001 | Approval | |
| apligraf (graftskin) | P950032/S016 | 06/20/2000 | 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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