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.
151 to 200 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
latitude wave communicator (model 6498) | P910077/S119 | 01/28/2013 | Review | Approval |
reliance 4-site defibrillator lead | P910073/S107 | 12/20/2012 | Review | Approval |
merlin home 6.1m | P910023/S307 | 12/19/2012 | Review | Approval |
merlin net 6.1m | P030054/S237 | 12/19/2012 | Review | Approval |
accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers | P880086/S202 | 12/04/2012 | Review | Approval |
atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds | P910023/S263 | 12/04/2012 | Review | Approval |
anthem, frontier ii crt-ps | P030035/S082 | 12/04/2012 | Review | Approval |
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds | P030054/S188 | 12/04/2012 | Review | Approval |
cognis, incepta, energen and punctua crt-d devices | P010012/S300 | 11/30/2012 | Review | Approval |
teligen, incepta, energen and punctua icd devices | P960040/S270 | 11/30/2012 | Review | Approval |
lifevest waerable defibrillator | P010030/S031 | 11/02/2012 | Review | Approval |
gem iii at | P980050/S076 | 10/26/2012 | Review | Approval |
concerta, consulta/consulta df4, & various insync families of icd's; concerto ii, maximo ii,protecta,protecta xt crt-d's | P010031/S329 | 10/26/2012 | Review | Approval |
entrust,secura,gem ii/iii vr/dr,intrinsic/intrinsic 30,maximo vr/dr,maximo ii,marquis vr/dr,protecta/protecta xt | P980016/S376 | 10/26/2012 | Review | Approval |
kronos lv-t crt-d and lumax 300/340 & 500/540 crt-d's & icd's | P050023/S053 | 10/03/2012 | Review | Approval |
stratos lv/lv-t | P070008/S031 | 10/03/2012 | Review | Approval |
belos dr/dr-t/vr/vr-t, lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's | P000009/S049 | 10/03/2012 | Review | Approval |
various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers | P950037/S105 | 10/03/2012 | Review | Approval |
durata leads | P950022/S079 | 09/13/2012 | Approval | |
tendril family of leads | P960013/S068 | 09/13/2012 | Review | Approval |
ddma software | P890003/S251 | 09/12/2012 | Review | Approval |
maximo ii df4 icd, secura df4 icd | P980016/S362 | 09/12/2012 | Review | Approval |
protecta df4 icd, protecta icd, protecta xt df4 icd, protecta xt icd | P980016/S361 | 09/10/2012 | Review | |
protecta crt-d, protecta df4 crt-d, protecta xt crt-d, protecta xt df4 crt-d | P010031/S314 | 09/10/2012 | Review | |
icd family of devices & fortify family of devices | P910023/S295 | 08/09/2012 | Review | Approval |
unify quadra crt-d, unify quadra assura | P030054/S223 | 08/09/2012 | Review | Approval |
concert ii, consulta, & maximo ii crt-ds | P010031/S296 | 06/04/2012 | Review | Approval |
maximo ii, secura & virtuoso ii dr/vr icds | P980016/S343 | 06/04/2012 | Review | Approval |
carelink device data management application (model 2491) | P890003/S247 | 06/04/2012 | Review | Approval |
advisa dr ipg | P980035/S264 | 06/04/2012 | Review | Approval |
consulta crt-p, syncra crt-p | P010015/S157 | 06/04/2012 | Review | Approval |
reocor s / d family of external pacemakers | P950037/S084 | 05/08/2012 | Review | Approval |
frontier/frontier ii/anthem family of crt-ps | P030035/S089 | 05/07/2012 | Review | Approval |
affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S211 | 05/07/2012 | Review | Approval |
sensolog/dialog/regency family of pacemakers | P880006/S075 | 05/07/2012 | Review | Approval |
microny family of pacemakers | P970013/S044 | 05/07/2012 | Review | Approval |
epic hf/atlas+hf/quadra assura/unify assura family of crt-ds | P030054/S206 | 05/07/2012 | Review | Approval |
cadence/ellipse/fortify assura family of icds | P910023/S279 | 05/07/2012 | Review | Approval |
stratos lv/lv-t | P070008/S028 | 05/04/2012 | Review | Approval |
belos dr/dr-t/vr/vr-t/lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t/xelos dr-t | P000009/S047 | 05/04/2012 | Review | Approval |
lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t | P050023/S048 | 05/04/2012 | Review | Approval |
cylos/dr/dr-t/vr/dromos dr/sr/sl/kairos dr/sr/sl/d/s/philos/dr/dr-t/sr/slr/d/s/philos ii d/dr/s/slr/sr/dr-t/protos dr/cl | P950037/S100 | 05/04/2012 | Review | Approval |
protects xt vr, protecta vr, secura vr maximo ii icd | P980016/S280 | 05/02/2012 | Review | Approval |
medtronic carelink monitor, cardiosight reader | P890003/S214 | 05/02/2012 | Review | Approval |
invive v172, v173 | P030005/S079 | 05/01/2012 | Review | Approval |
spectranetics laser sheath device | P960042/S031 | 04/20/2012 | Review | Approval |
paradym crt | P060027/S032 | 04/10/2012 | Approval | |
paradym vr/dr | P980049/S065 | 04/10/2012 | Approval | |
cadence family of icds | P910023/S270 | 03/09/2012 | Review | Approval |
epic hf/atlas + hf family | P030054/S196 | 03/09/2012 | 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
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