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.
1 to 50 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
apligraf (graftskin) | P950032/S016 | 06/20/2000 | Approval | |
integrity afx dr model 5346 dual chamber pulse generator and programmer software model 3307, v2.2a | P880086/S083 | 07/11/2001 | Approval | |
home monitoring system | P950037/S019 | 10/11/2001 | Approval | |
floseal hemostatic matrix 5 ml/10 ml kit | P990009/S025 | 01/07/2010 | Review | Approval |
juvederm ultra xc and juvederm ultra plus xc | P050047/S005 | 01/07/2010 | 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 |
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 |
tendril sts lead model 1988tc | P960013/S054 | 04/14/2010 | Review | Approval |
st jude medical, merlin psa ex3100 system | P030054/S146 | 05/03/2010 | 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 |
quickflex u model 1258t lead | P030054/S130 | 05/10/2010 | Review | Approval |
xc202 ceramic capacitor | P980035/S153 | 06/18/2010 | Review | Approval |
reliaty/model 3145 pacing system analyzer | P950037/S079 | 09/02/2010 | 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 |
linox smart steroid-eluting dual-coil icd leads | P980023/S038 | 09/17/2010 | Review | Approval |
enrythm ipg | P980016/S237 | 10/19/2010 | Review | Approval |
entrust icd family | P980035/S166 | 10/19/2010 | Review | Approval |
carelink ddma software and carelink monitor | P890003/S191 | 10/19/2010 | Review | Approval |
endotak reliance 4-site leads and accessories | P910073/S077 | 11/10/2010 | Review | Approval |
lead tunneler model 6888 | P830060/S062 | 11/10/2010 | Review | Approval |
teligen 4-site models | P960040/S198 | 11/10/2010 | Review | Approval |
cognis 4-site models | P010012/S212 | 11/10/2010 | Review | Approval |
optisense model 1999 lead | P960013/S057 | 11/26/2010 | Review | Approval |
evia/entovis dr/dr-t/sr-t & various other models of pulse generators | P950037/S083 | 11/26/2010 | Review | Approval |
belos/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds | P000009/S040 | 11/26/2010 | Review | Approval |
various models of lumax icd/crt-d families | P050023/S033 | 11/26/2010 | Review | Approval |
stratos lv/lv-t crt-p | P070008/S017 | 11/26/2010 | Review | Approval |
medtronics adapta, versa, sensia and relia implantable pulse generator | P980035/S150 | 12/08/2010 | Review | Approval |
corox otw-l bp left ventricular pacing lead | P070008/S015 | 12/23/2010 | Review | Approval |
durata family of leads | P950022/S069 | 01/24/2011 | Review | Approval |
epic hr/atlas + hf family of crt-ds | P030054/S153 | 03/04/2011 | Review | Approval |
frontier/frontier 2 family of crt-ps | P030035/S070 | 03/04/2011 | Review | Approval |
senslog/dialog/regency family of pacemakers | P880006/S067 | 03/04/2011 | Review | Approval |
affinity/integrity/victory family of pacemakers | P880086/S189 | 03/04/2011 | Review | Approval |
cadence family of icds | P910023/S236 | 03/04/2011 | Review | Approval |
microny family of pacemakers | P970013/S034 | 03/04/2011 | Review | Approval |
consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization | P010015/S084 | 03/22/2011 | Review | Approval |
carelink monitor models 2490g/2491ddma | P890003/S189 | 03/22/2011 | Review | Approval |
dema ipg/c & t series ipgs | P990001/S068 | 03/22/2011 | Review | Approval |
carelink ddma software and carelink monitor | P890003/S192 | 03/22/2011 | Review | Approval |
kappa 400 dr/sr ipg | P970012/S068 | 03/22/2011 | 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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