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 |
|---|---|---|---|---|
| xc202 ceramic capacitor | P980035/S153 | 06/18/2010 | Review | Approval |
| medtronics adapta, versa, sensia and relia implantable pulse generator | P980035/S150 | 12/08/2010 | Review | Approval |
| advisa dr ipg | P980035/S134 | 04/04/2011 | Review | Approval |
| gem iii at | P980050/S076 | 10/26/2012 | Review | Approval |
| paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 | P980049/S059 | 09/09/2010 | Review | Approval |
| transvene cs/svc lead | P980050/S057 | 05/13/2011 | Review | Approval |
| paradym vr model 8250 & dr model 8550 | P980049/S050 | 04/07/2010 | Review | Approval |
| vigila and volta and passive fixation bipolar steroid eluting icd leads | P980023/S046 | 02/22/2012 | Review | Approval |
| linox smart steroid-eluting dual-coil icd leads | P980023/S038 | 09/17/2010 | Review | Approval |
| kappa 400 dr/sr ipgs | P970012/S081 | 05/13/2011 | Review | Approval |
| kappa 400 dr/sr ipg | P970012/S068 | 03/22/2011 | Review | Approval |
| microny family of pacemakers | P970013/S044 | 05/07/2012 | Review | Approval |
| microny family of pacemakers | P970013/S040 | 08/03/2011 | Review | Approval |
| microny family of pacemakers | P970013/S038 | 04/04/2011 | Review | Approval |
| microny family of pacemakers | P970013/S034 | 03/04/2011 | Review | Approval |
| teligen, incepta, energen and punctua icd devices | P960040/S270 | 11/30/2012 | Review | Approval |
| incepta, energen, punctua and teligen icds | P960040/S235 | 11/17/2011 | Review | Approval |
| teligen 4-site models | P960040/S198 | 11/10/2010 | Review | Approval |
| tendril family of leads | P960013/S068 | 09/13/2012 | Review | Approval |
| tendril sts 1988tc and 2088tc | P960013/S066 | 11/01/2011 | Review | Approval |
| optisense model 1999 lead | P960013/S057 | 11/26/2010 | Review | Approval |
| tendril sts lead model 1988tc | P960013/S054 | 04/14/2010 | Review | Approval |
| spectranetics laser sheath device | P960042/S031 | 04/20/2012 | Review | Approval |
| transcyte human fibroblast-derived temporary skin substitute | P960007/S021 | 09/20/2011 | Review | Approval |
| various models of ipg's: actros, axios, cylos, dromos, kairos, philos/ii, protos, etc. | P950037/S116 | 03/18/2013 | Review | Approval |
| various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers | P950037/S105 | 10/03/2012 | 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 |
| evia/entovis/estella/effecta/ecuro | P950037/S098 | 09/30/2011 | Review | Approval |
| evia / entovis family of pulse generators | P950037/S091 | 03/25/2011 | Review | Approval |
| implantable pacemaker pulse generator,pacemaker programming | P950037/S089 | 04/15/2011 | Review | Approval |
| reliaty / model 3145 family of pacing system analyzers | P950037/S088 | 04/20/2011 | Review | Approval |
| reocor s / d family of external pacemakers | P950037/S084 | 05/08/2012 | Review | Approval |
| evia/entovis dr/dr-t/sr-t & various other models of pulse generators | P950037/S083 | 11/26/2010 | Review | Approval |
| reliaty/model 3145 pacing system analyzer | P950037/S079 | 09/02/2010 | Review | Approval |
| evia / entovis & various other pulse generators | P950037/S072 | 05/07/2010 | Review | Approval |
| durata family of leads | P950022/S069 | 01/24/2011 | Review | Approval |
| legend plus family of pacemakers | P930022/S012 | 05/13/2011 | Review | Approval |
| medtronic sprint quattro secure lead model 6947m | P920015/S055 | 01/09/2012 | Review | Approval |
| merlin home 6.1m | P910023/S307 | 12/19/2012 | Review | Approval |
| icd family of devices & fortify family of devices | P910023/S295 | 08/09/2012 | Review | Approval |
| cadence/ellipse/fortify assura family of icds | P910023/S279 | 05/07/2012 | Review | Approval |
| cadence family of icds | P910023/S270 | 03/09/2012 | Review | Approval |
| cadence family of icds | P910023/S264 | 08/03/2011 | Review | Approval |
| atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds | P910023/S263 | 12/04/2012 | Review | Approval |
| cadence/current/fortify families of icds | P910023/S257 | 06/21/2011 | Review | Approval |
| cadence family of icds | P910023/S254 | 04/04/2011 | Review | Approval |
| cadence family of icds | P910023/S236 | 03/04/2011 | Review | Approval |
| fortify dr / vr icd systems | P910023/S226 | 05/07/2010 | Review | Approval |
| cadence family of icds | P910023/S215 | 01/29/2010 | Review | Approval |
| latitude wave communicator (model 6498) | P910077/S119 | 01/28/2013 | Review | Approval |
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