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.
51 to 100 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
cellpaker plasma collection device | P050044/S019 | 01/31/2012 | Review | Approval |
juvederm ultra xc and juvederm ultra plus xc | P050047/S005 | 01/07/2010 | Review | Approval |
restylane/restylane-l/ perlane/ perlane-l , restylane silk(injectable gels) | P040024/S079 | 01/26/2016 | Review | |
restylane injectable gel | P040024/S052 | 07/18/2011 | Review | Approval |
restylane l and perlane l injectable gels | P040024/S039 | 01/29/2010 | Review | Approval |
quadra assura / unify assura family of crt-d's | P030054/S284 | 08/27/2015 | Review | |
quadra assura/unify assura family of crt-d's | P030054/S273 | 09/12/2014 | Review | Approval |
quadra assura/unify assura family pf crt-ds | P030054/S254 | 02/26/2014 | Review | Approval |
quadra assura/unify assura family of crt-ds | P030054/S238 | 06/06/2013 | Review | Approval |
merlin net 6.1m | P030054/S237 | 12/19/2012 | Review | Approval |
epic hf/atlas + hf/quandra assura/unify assura family of crt-d's | P030054/S226 | 04/10/2014 | Review | Approval |
unify quadra crt-d, unify quadra assura | P030054/S223 | 08/09/2012 | Review | Approval |
epic hf/atlas+hf/quadra assura/unify assura family of crt-ds | P030054/S206 | 05/07/2012 | Review | Approval |
epic hf/atlas + hf family | P030054/S196 | 03/09/2012 | Review | Approval |
epic hf/atlas + hf family of crt-ds | P030054/S189 | 08/03/2011 | Review | Approval |
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds | P030054/S188 | 12/04/2012 | Review | Approval |
epic hf/atlas+hf/promote/unify families of crt-ds | P030054/S181 | 06/21/2011 | Review | Approval |
epic hf/atlas+hf hamily of crt-ds | P030054/S177 | 04/04/2011 | Review | Approval |
cardiac resynchronization therapy defibrillator (crt-d) | P030054/S173 | 11/29/2011 | Review | Approval |
epic hr/atlas + hf family of crt-ds | P030054/S153 | 03/04/2011 | Review | Approval |
st jude medical, merlin psa ex3100 system | P030054/S146 | 05/03/2010 | Review | Approval |
unify crt-d system | P030054/S141 | 05/07/2010 | Review | Approval |
frontier / frontier ii / anthem family of crt-p's | P030035/S133 | 08/27/2015 | Review | |
epic hf crt-d system | P030054/S131 | 01/29/2010 | Review | Approval |
quickflex u model 1258t lead | P030054/S130 | 05/10/2010 | Review | Approval |
frontier/ frontier ii / anthem family of crt-p's | P030035/S123 | 09/12/2014 | Review | Approval |
frontier/frontier ii/ anthem family of crt-ps | P030035/S115 | 02/26/2014 | Review | Approval |
frontier/frontier ii/anthem family of crt-ps | P030035/S107 | 06/06/2013 | Review | Approval |
frontier/ frontier ii /anthem family of crt-p's | P030035/S098 | 04/10/2014 | Review | Approval |
intua cardiac resynchronization therapy-pacemaker (crt-p) | P030005/S092 | 05/23/2013 | Review | Approval |
frontier/frontier ii/anthem family of crt-ps | P030035/S089 | 05/07/2012 | Review | Approval |
cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 | P030005/S088 | 03/12/2013 | Review | Approval |
frontier/frontierii/anthem family of crt-ps | P030035/S083 | 08/03/2011 | Review | Approval |
anthem, frontier ii crt-ps | P030035/S082 | 12/04/2012 | Review | Approval |
invive v172, v173 | P030005/S079 | 05/01/2012 | Review | Approval |
frontier/frontier ii family of crt-ps | P030035/S075 | 04/04/2011 | Review | Approval |
frontier/frontier 2 family of crt-ps | P030035/S070 | 03/04/2011 | Review | Approval |
memorygel/memorygel xtra breast implants | P030053/S062 | 10/27/2021 | Approval | |
medtronic selectsecure lead model 3830 | P030036/S004 | 03/30/2011 | Review | Approval |
natrelle silicone filled breast implants | P020056/S054 | 10/27/2021 | Approval | |
brava crt-d, brava quad crt-d, viva quad s crt-d, viva quad xt crt-d, viva s crt-d, viva xt crt-d | P010031/S511 | 10/29/2015 | Review | |
brava,brava quad,concerto ii,consulta,maximo ii,protecta,protecta xt,viva quad s, viva quad xt,viva s, viva xt crt-ds, c | P010031/S478 | 10/19/2015 | 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 |
concerto ii crt-d,maximo ii crt-d,consulta crt-d,consulta crt-d df4,maximo ii crt-d df4 | P010031/S414 | 07/09/2014 | Review | Approval |
brava crt-d,viva s crt-d,viva xt crt-d,viva/brava/evera programmer application software | P010031/S413 | 02/27/2014 | Review | Approval |
origen, inogen, and dynagen crt-d, incepta energen punctua crt-d, cognis crt-d | P010012/S405 | 12/21/2015 | Review | |
insync ii protect icd, iiimarquis icd, marquis icd, maximo icd, brava crt-d, concerto icd, ii crt-d, consulta icd, maxim | P010031/S397 | 02/14/2014 | Review | Approval |
insync ii protect, insync iii marquis,insync marquis, insync maximo icds | P010031/S386 | 09/27/2013 | Review | Approval |
insync ii p rotect icd, insync iii marquis icd, insync marquis icd, insync maximo icd | P010031/S363 | 05/24/2013 | Review | Approval |
dynagen & dynagen x4 crt-d's; inogen & inogen x4 crt-d's; origen & origen x4 crt-d's; cognis crt-d | P010012/S341 | 04/11/2014 | 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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