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.
51 to 100 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
secura dr/vr/maximo ii vr/dr/virtuoso ii dr/vr icds | P980016/S240 | 03/22/2011 | Review | Approval |
kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/senia ipgs | P980035/S168 | 03/22/2011 | Review | Approval |
insync crt-p & insync iii crt-p | P010015/S086 | 03/22/2011 | Review | Approval |
concerto ii/consulta/maximo ii crt-ds | P010031/S198 | 03/22/2011 | Review | Approval |
protecta xt crt-d and protecta crt-d implantable cardioverter defibrillators with cardiac resynchronization; model sw009 | P010031/S171 | 03/25/2011 | Review | Approval |
medtronic protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, implantable cardioverter defibrillators | P980016/S211 | 03/25/2011 | Review | Approval |
medtronic carelink monitor model 2490c, cardiosight reader | P890003/S177 | 03/25/2011 | Review | Approval |
evia / entovis family of pulse generators | P950037/S091 | 03/25/2011 | Review | Approval |
medtronic selectsecure lead model 3830 | P030036/S004 | 03/30/2011 | Review | Approval |
medtronic attain ability straight model 4396 left ventricular lead | P080006/S004 | 03/31/2011 | Review | Approval |
medtronic attain ability plus model 4296 lead | P080006/S002 | 04/01/2011 | Review | Approval |
advisa dr ipg | P980035/S134 | 04/04/2011 | Review | Approval |
carelink monitor & cardiosight reader | P890003/S169 | 04/04/2011 | Review | Approval |
consulta crt-d/concerto ii crt-d/maximo crt-d icds | P010031/S150 | 04/04/2011 | Review | Approval |
secura dr/vr, virtuoso ii dr/vr, maximo ii dr/vr icds | P980016/S187 | 04/04/2011 | Review | Approval |
epic hf/atlas+hf hamily of crt-ds | P030054/S177 | 04/04/2011 | Review | Approval |
frontier/frontier ii family of crt-ps | P030035/S075 | 04/04/2011 | Review | Approval |
sensolog/dialog/regency family of pacemakers | P880006/S070 | 04/04/2011 | Review | Approval |
affinity/integrity/victory family of pacemakers | P880086/S195 | 04/04/2011 | Review | Approval |
cadence family of icds | P910023/S254 | 04/04/2011 | Review | Approval |
microny family of pacemakers | P970013/S038 | 04/04/2011 | Review | Approval |
implantable pacemaker pulse generator,pacemaker programming | P950037/S089 | 04/15/2011 | Review | Approval |
implantable cv defibrillator/pacemaker programmer/icd monitoring system | P000009/S042 | 04/15/2011 | 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/S039 | 04/15/2011 | Review | Approval |
stratos lv/lv-t | P070008/S019 | 04/15/2011 | Review | Approval |
lifevest wearable defibrillator | P010030/S023 | 04/19/2011 | Review | Approval |
reliaty / model 3145 family of pacing system analyzers | P950037/S088 | 04/20/2011 | Review | Approval |
carelink home monitor and cardiosight monitor | P890003/S209 | 05/04/2011 | Review | Approval |
medtronics carelink home monitor and cardiosight reader | P890003/S211 | 05/13/2011 | Review | Approval |
concerto ii/maximo ii/consulta crt-ds | P010031/S228 | 05/13/2011 | Review | Approval |
dual chamber, implantable pulse generator | P820003/S104 | 05/13/2011 | Review | Approval |
kappa 400 dr/sr ipgs | P970012/S081 | 05/13/2011 | Review | Approval |
virtuoso ii/secura/maximo ii icds | P980016/S273 | 05/13/2011 | Review | Approval |
kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/sensia ipgs | P980035/S200 | 05/13/2011 | Review | Approval |
insync crt-p/insync iii crt-p | P010015/S107 | 05/13/2011 | Review | Approval |
medtronic carelink programmer | P850051/S074 | 05/13/2011 | Review | Approval |
legend plus family of pacemakers | P930022/S012 | 05/13/2011 | Review | Approval |
ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar | P900061/S098 | 05/13/2011 | Review | Approval |
dema ipg/c & t series ipgs | P990001/S082 | 05/13/2011 | Review | Approval |
transvene cs/svc lead | P980050/S057 | 05/13/2011 | Review | Approval |
surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin | P990004/S019 | 05/17/2011 | Review | Approval |
cadence/current/fortify families of icds | P910023/S257 | 06/21/2011 | Review | Approval |
epic hf/atlas+hf/promote/unify families of crt-ds | P030054/S181 | 06/21/2011 | Review | Approval |
restylane injectable gel | P040024/S052 | 07/18/2011 | Review | Approval |
affinity/integrity/victory/zephyr/accent family of pacemakers | P880086/S203 | 08/03/2011 | Review | Approval |
frontier/frontierii/anthem family of crt-ps | P030035/S083 | 08/03/2011 | Review | Approval |
sensolog/dialog/regency family of pacemakers | P880006/S071 | 08/03/2011 | Review | Approval |
microny family of pacemakers | P970013/S040 | 08/03/2011 | Review | Approval |
cadence family of icds | P910023/S264 | 08/03/2011 | Review | Approval |
epic hf/atlas + hf family of crt-ds | P030054/S189 | 08/03/2011 | 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
-