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 |
|---|---|---|---|---|
| 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 |
| various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers | P950037/S105 | 10/03/2012 | Review | Approval |
| various models of ipg's: actros, axios, cylos, dromos, kairos, philos/ii, protos, etc. | P950037/S116 | 03/18/2013 | Review | Approval |
| entovis promri pacemaker system | P950037/S132 | 05/04/2014 | 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 |
| linox smart(s65)(sd65/18)(sdx65/15&65/17),protego df-1(s65)(sd65/18)(dx65/15&65/17),protego(s65&75)(sd65/16,65/18,75/18) | P950037/S151 | 12/21/2015 | Review | |
| transcyte human fibroblast-derived temporary skin substitute | P960007/S021 | 09/20/2011 | Review | Approval |
| spectranetics laser sheath device | P960042/S031 | 04/20/2012 | Review | Approval |
| spectranetics laser sheath | P960042/S043 | 06/14/2013 | Review | Approval |
| tendril sts lead model 1988tc | P960013/S054 | 04/14/2010 | Review | Approval |
| optisense model 1999 lead | P960013/S057 | 11/26/2010 | Review | Approval |
| fineline ii sterox lead | P960004/S060 | 09/09/2013 | Review | Approval |
| tendril sts 1988tc and 2088tc | P960013/S066 | 11/01/2011 | Review | Approval |
| tendril family of leads | P960013/S068 | 09/13/2012 | Review | Approval |
| teligen 4-site models | P960040/S198 | 11/10/2010 | Review | Approval |
| incepta, energen, punctua and teligen icds | P960040/S235 | 11/17/2011 | Review | Approval |
| teligen, incepta, energen and punctua icd devices | P960040/S270 | 11/30/2012 | 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 |
| origen, inogen, and dynagen icd, incepta, energen, and punctua icd, teligen icd | P960040/S360 | 12/21/2015 | Review | |
| microny family of pacemakers | P970013/S034 | 03/04/2011 | Review | Approval |
| microny family of pacemakers | P970013/S038 | 04/04/2011 | Review | Approval |
| microny family of pacemakers | P970013/S040 | 08/03/2011 | Review | Approval |
| microny family of pacemakers | P970013/S044 | 05/07/2012 | Review | Approval |
| microny family of pacemakers | P970013/S050 | 04/10/2014 | Review | Approval |
| microny family pacemakers | P970013/S054 | 06/06/2013 | Review | Approval |
| microny family of pacemakers | P970013/S057 | 02/26/2014 | Review | Approval |
| microny family of pacemakers | P970013/S060 | 09/12/2014 | Review | Approval |
| microny family of pacemakers | P970013/S064 | 08/27/2015 | Review | |
| kappa 400 dr/sr ipg | P970012/S068 | 03/22/2011 | Review | Approval |
| kappa 400 dr/sr ipgs | P970012/S081 | 05/13/2011 | Review | Approval |
| kappa 400 dr ipg,kappa 400 sr ipg | P970012/S096 | 10/19/2015 | Review | Approval |
| linox smart steroid-eluting dual-coil icd leads | P980023/S038 | 09/17/2010 | Review | Approval |
| vigila and volta and passive fixation bipolar steroid eluting icd leads | P980023/S046 | 02/22/2012 | Review | Approval |
| linox(smart) s dx steroid-eluting single-coil icd leads | P980023/S049 | 02/13/2013 | Review | Approval |
| paradym vr model 8250 & dr model 8550 | P980049/S050 | 04/07/2010 | Review | Approval |
| transvene cs/svc lead | P980050/S057 | 05/13/2011 | Review | Approval |
| protego family of icd leads | P980023/S057 | 07/03/2014 | Review | Approval |
| paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 | P980049/S059 | 09/09/2010 | Review | 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 |
| paradym vr/dr | P980049/S065 | 04/10/2012 | Approval | |
| paradym rf vr icds | P980049/S071 | 05/09/2013 | Approval | |
| linox smart s65,linox smart sd 65/18,linox s dx 65/15,linox s dx 65/17,protego df-1 s 65,protego df-1 sd 65/18,protego d | P980023/S072 | 12/21/2015 | Review | |
| gem iii at | P980050/S076 | 10/26/2012 | Review | Approval |
| jewel af icd | P980050/S097 | 10/19/2015 | Review | Approval |
| instensia icd | P980049/S099 | 11/04/2014 | Approval | |
| advisa dr ipg | P980035/S134 | 04/04/2011 | Review | Approval |
| medtronics adapta, versa, sensia and relia implantable pulse generator | P980035/S150 | 12/08/2010 | Review | Approval |
| xc202 ceramic capacitor | P980035/S153 | 06/18/2010 | Review | Approval |
| entrust icd family | P980035/S166 | 10/19/2010 | 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 |
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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