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.
51 to 100 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
intensia crt-d | P060027/S066 | 11/04/2014 | Approval | |
instensia icd | P980049/S099 | 11/04/2014 | Approval | |
volta(1cr/2cr/ct/2ct) icd lead, protego (s/sd/t/td) icd lead,kainox vcs 60 icd leadlinox smart (s/sd/t/td/s dx) icd lead | P980023/S060 | 09/16/2014 | Review | Approval |
celerity 2d/3d/pilot steroid-eluting lv lead, corox (-s/-l) bp steroid-eluting lv lead | P070008/S054 | 09/16/2014 | Review | Approval |
dextrus, selox st/jt, setrox s, and tilda t/jt/r steroid-eluting pacing leads; solox slx -bp pacing lead | P950037/S138 | 09/16/2014 | Review | Approval |
ellipse / fortify assura family of icd's | P910023/S342 | 09/12/2014 | Review | Approval |
frontier/ frontier ii / anthem family of crt-p's | P030035/S123 | 09/12/2014 | Review | Approval |
quadra assura/unify assura family of crt-d's | P030054/S273 | 09/12/2014 | Review | Approval |
affinity, integrity, victory, zephyr, & accent family of pacemakers | P880086/S245 | 09/12/2014 | Review | Approval |
microny family of pacemakers | P970013/S060 | 09/12/2014 | Review | Approval |
sensolog/ dialog/regency family of pacemakers | P880006/S089 | 09/12/2014 | Review | Approval |
attain starfix lead | P060039/S059 | 09/04/2014 | Review | Approval |
subcutaneous implantable defibrillator (s-icd) system | P110042/S029 | 08/22/2014 | Review | Approval |
advisa dr,advisa dr mri | P980035/S358 | 07/09/2014 | Review | Approval |
carelink enore programmer,carelink 2090 programmer,carelink home monitor,carelink express monitor,cardiosight reader,dev | P890003/S297 | 07/09/2014 | Review | Approval |
viva crt-p,consulta crt-p,syncra crt-p | P010015/S227 | 07/09/2014 | Review | Approval |
maximo ii dr,maximo ii vr,virtuoso ii vr,secura dr,secura vr | P980016/S452 | 07/09/2014 | Review | Approval |
concerto ii crt-d,maximo ii crt-d,consulta crt-d,consulta crt-d df4,maximo ii crt-d df4 | P010031/S414 | 07/09/2014 | Review | Approval |
protego family of icd leads | P980023/S057 | 07/03/2014 | Review | Approval |
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 |
ilesto/iforia 5/7 vrt/drt icd's, ilesto/iforia 5/7 hf-t crt-d | P050023/S076 | 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 |
ilesto icd's and crt-d's | P050023/S074 | 05/04/2014 | Review | Approval |
entovis promri pacemaker system | P950037/S132 | 05/04/2014 | Review | Approval |
evia crt-p's | P070008/S050 | 05/04/2014 | Review | Approval |
xelos dr-t icd's | P000009/S057 | 05/04/2014 | Review | Approval |
dynagen el & mini icd's; inogen el & mini icd's; origen el & mini icd's; teligen icd | P960040/S306 | 04/11/2014 | Review | Approval |
model 3140 zoom wireless transmitter and model 3120 zoom latitude programmer/recorder/monitor (prm) | P910077/S139 | 04/11/2014 | Review | Approval |
dynagen & dynagen x4 crt-d's; inogen & inogen x4 crt-d's; origen & origen x4 crt-d's; cognis crt-d | P010012/S341 | 04/11/2014 | Review | Approval |
epic hf/atlas + hf/quandra assura/unify assura family of crt-d's | P030054/S226 | 04/10/2014 | Review | Approval |
affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S220 | 04/10/2014 | Review | Approval |
cadence/ellipse/fortify assura family of icd's | P910023/S297 | 04/10/2014 | Review | Approval |
frontier/ frontier ii /anthem family of crt-p's | P030035/S098 | 04/10/2014 | Review | Approval |
sensolog/ dialog/regency family of pacemakers | P880006/S081 | 04/10/2014 | Review | Approval |
microny family of pacemakers | P970013/S050 | 04/10/2014 | Review | Approval |
lattitude consult system | P910077/S138 | 03/20/2014 | Review | Approval |
paradym rf:models vr 9250, dr 9550, crt-d 9750; paradym models vr 8250, dr 8550, crt-d 8750 | P060027/S053 | 03/06/2014 | Review | Approval |
mycarelink monitor, | P890003/S295 | 02/27/2014 | Review | Approval |
brava crt-d,viva s crt-d,viva xt crt-d,viva/brava/evera programmer application software | P010031/S413 | 02/27/2014 | Review | Approval |
evera s dr icd,evera s vr icd, evera xt dr icd,evera xt vr icd, viva/brava/evera programmer application software | P980016/S451 | 02/27/2014 | Review | Approval |
ellipse/fortify assura family of icds | P910023/S323 | 02/26/2014 | Review | Approval |
quadra assura/unify assura family pf crt-ds | P030054/S254 | 02/26/2014 | Review | Approval |
sensolog/dialog/ regency family of pacemakers | P880006/S087 | 02/26/2014 | Review | Approval |
frontier/frontier ii/ anthem family of crt-ps | P030035/S115 | 02/26/2014 | Review | Approval |
microny family of pacemakers | P970013/S057 | 02/26/2014 | Review | Approval |
affinity/ integrity/ victory/ zephyr/accent family of pacemakers | P880086/S237 | 02/26/2014 | Review | Approval |
capsure sense lead | P830061/S086 | 02/18/2014 | Review | Approval |
mycarelink patient monitor, device data management application, application software | P890003/S285 | 02/14/2014 | 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
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