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 |
|---|---|---|---|---|
| xelos dr-t icd's | P000009/S057 | 05/04/2014 | Review | Approval |
| xc202 ceramic capacitor | P980035/S153 | 06/18/2010 | 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 |
| viva quad xt crt-d,viva quad s crt-d,brava quad crt-d,viva quad c crt-d,viva/brava/evera software application | P010031/S442 | 07/03/2014 | Review | Approval |
| viva crt-p,consulta crt-p,syncra crt-p | P010015/S227 | 07/09/2014 | Review | Approval |
| vitatron c20 sr ipg,vitatron c60 dr ipg,vitatron t20 sr ipg,vitatron t60 dr ipg | P990001/S119 | 10/19/2015 | Review | Approval |
| vitagel surgical hemostat | P050044/S021 | 10/11/2013 | Review | |
| vistatron c&t series (model vsf04 v8.0, model vsf 12 v8.0, model vsf08 v8.0) | P990001/S105 | 03/13/2013 | Review | Approval |
| virtuoso ii/secura/maximo ii icds | P980016/S273 | 05/13/2011 | Review | Approval |
| vigila and volta and passive fixation bipolar steroid eluting icd leads | P980023/S046 | 02/22/2012 | Review | Approval |
| versatrax pacing system | P820003/S117 | 05/30/2013 | Review | Approval |
| various models of lumax icd/crt-d families | P050023/S033 | 11/26/2010 | 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 |
| unify quadra crt-d, unify quadra assura | P030054/S223 | 08/09/2012 | Review | Approval |
| unify crt-d system | P030054/S141 | 05/07/2010 | Review | Approval |
| transvene cs/svc lead | P980050/S057 | 05/13/2011 | Review | Approval |
| transcyte human fibroblast-derived temporary skin substitute | P960007/S021 | 09/20/2011 | Review | Approval |
| tendril sts lead model 1988tc | P960013/S054 | 04/14/2010 | 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, incepta, energen and punctua icd devices | P960040/S270 | 11/30/2012 | Review | Approval |
| teligen 4-site models | P960040/S198 | 11/10/2010 | Review | Approval |
| synergyst ii pacing system | P890003/S265 | 05/30/2013 | Review | Approval |
| symbios,synergyst ipgs | P820003/S132 | 10/19/2015 | Review | Approval |
| surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin | P990004/S019 | 05/17/2011 | Review | Approval |
| subcutaneous implantable defibrillator (s-icd) system | P110042/S009 | 08/28/2013 | Review | Approval |
| subcutaneous implantable defibrillator (s-icd) system | P110042/S029 | 08/22/2014 | Review | Approval |
| stratos lv/lv-t, evia and entovis hf/hf-t crt-p's | P070008/S036 | 03/18/2013 | Review | Approval |
| stratos lv/lv-t crt-p | P070008/S017 | 11/26/2010 | Review | Approval |
| stratos lv/lv-t | P070008/S019 | 04/15/2011 | Review | Approval |
| stratos lv/lv-t | P070008/S028 | 05/04/2012 | Review | Approval |
| stratos lv/lv-t | P070008/S031 | 10/03/2012 | Review | Approval |
| st jude medical, merlin psa ex3100 system | P030054/S146 | 05/03/2010 | Review | Approval |
| sprint quattro secure s mri surescan and sprint quattro secure mri surescan | P920015/S151 | 09/11/2015 | Review | |
| sprint quattro secure s mri surescan ; sprint quattro secure mri surescan | P920015/S163 | 02/01/2016 | Review | |
| spectranetics laser sheath device | P960042/S031 | 04/20/2012 | Review | Approval |
| spectranetics laser sheath | P960042/S043 | 06/14/2013 | Review | Approval |
| sientra opus silicone gel breast implants | P070004/S033 | 10/27/2021 | Approval | |
| sensolog/dialog/regency family of pacemakers | P880006/S084 | 06/06/2013 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S075 | 05/07/2012 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S071 | 08/03/2011 | Review | Approval |
| sensolog/dialog/regency family of pacemakers | P880006/S070 | 04/04/2011 | Review | Approval |
| sensolog/dialog/ regency family of pacemakers | P880006/S087 | 02/26/2014 | Review | Approval |
| sensolog/ dialog/regency family of pacemakers | P880006/S081 | 04/10/2014 | Review | Approval |
| sensolog/ dialog/regency family of pacemakers | P880006/S089 | 09/12/2014 | Review | Approval |
| sensolog / dialog/ regency family of pacemakers | P880006/S093 | 08/27/2015 | Review | |
| senslog/dialog/regency family of pacemakers | P880006/S067 | 03/04/2011 | Review | Approval |
| secura dr/vr/maximo ii vr/dr/virtuoso ii dr/vr icds | P980016/S240 | 03/22/2011 | Review | Approval |
| secura dr/vr, virtuoso ii dr/vr, maximo ii dr/vr icds | P980016/S187 | 04/04/2011 | 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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