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 |
|---|---|---|---|---|
| microny family pacemakers | P970013/S054 | 06/06/2013 | Review | Approval |
| microny family of pacemakers | P970013/S050 | 04/10/2014 | 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 |
| origen, inogen, and dynagen icd, incepta, energen, and punctua icd, teligen icd | P960040/S360 | 12/21/2015 | Review | |
| dynagen el & mini icd's; inogen el & mini icd's; origen el & mini icd's; teligen icd | P960040/S306 | 04/11/2014 | 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 |
| fineline ii sterox lead | P960004/S060 | 09/09/2013 | 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 | P960042/S043 | 06/14/2013 | 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 |
| 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 | |
| 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 |
| entovis promri pacemaker system | P950037/S132 | 05/04/2014 | 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 |
| durata leads | P950022/S079 | 09/13/2012 | Approval | |
| reliaty/model 3145 pacing system analyzer | P950037/S079 | 09/02/2010 | Review | Approval |
| reply/esprit sr and dr model pacemakers | P950029/S079 | 06/20/2013 | 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 |
| home monitoring system | P950037/S019 | 10/11/2001 | Approval | |
| apligraf (graftskin) | P950032/S016 | 06/20/2000 | Approval | |
| capsurefix novus mri surescan | P930039/S140 | 02/01/2016 | Review | |
| 5076 capsurefix novus surescan leads | P930039/S138 | 09/11/2015 | Review | |
| capsurefix novus mri surescan lead model 5076 | P930039/S130 | 06/22/2015 | Review | |
| legend plus ipg | P930022/S017 | 10/19/2015 | Review | Approval |
| legend plus family of pacemakers | P930022/S012 | 05/13/2011 | Review | Approval |
| sprint quattro secure s mri surescan ; sprint quattro secure mri surescan | P920015/S163 | 02/01/2016 | Review | |
| sprint quattro secure s mri surescan and sprint quattro secure mri surescan | P920015/S151 | 09/11/2015 | Review | |
| medtronic pcd tachyarrhythmia control system | P920015/S146 | 10/19/2015 | Review | Approval |
| model 5019 high voltage (hv) splitter/adaptor kit | P920015/S093 | 02/13/2013 | Review | Approval |
| medtronic sprint quattro secure lead model 6947m | P920015/S055 | 01/09/2012 | Review | Approval |
| ellipse/fortify assura family of icd's | P910023/S355 | 08/27/2015 | Review | |
| ellipse / fortify assura family of icd's | P910023/S342 | 09/12/2014 | 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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