Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
-
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.
251 to 300 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
quickflex u model 1258t lead | P030054/S130 | 05/10/2010 | Review | Approval |
epic hf crt-d system | P030054/S131 | 01/29/2010 | Review | Approval |
frontier / frontier ii / anthem family of crt-p's | P030035/S133 | 08/27/2015 | Review | |
unify crt-d system | P030054/S141 | 05/07/2010 | Review | Approval |
st jude medical, merlin psa ex3100 system | P030054/S146 | 05/03/2010 | Review | Approval |
epic hr/atlas + hf family of crt-ds | P030054/S153 | 03/04/2011 | Review | Approval |
cardiac resynchronization therapy defibrillator (crt-d) | P030054/S173 | 11/29/2011 | Review | Approval |
epic hf/atlas+hf hamily of crt-ds | P030054/S177 | 04/04/2011 | Review | Approval |
epic hf/atlas+hf/promote/unify families of crt-ds | P030054/S181 | 06/21/2011 | Review | Approval |
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds | P030054/S188 | 12/04/2012 | Review | Approval |
epic hf/atlas + hf family of crt-ds | P030054/S189 | 08/03/2011 | Review | Approval |
epic hf/atlas + hf family | P030054/S196 | 03/09/2012 | Review | Approval |
epic hf/atlas+hf/quadra assura/unify assura family of crt-ds | P030054/S206 | 05/07/2012 | Review | Approval |
unify quadra crt-d, unify quadra assura | P030054/S223 | 08/09/2012 | Review | Approval |
epic hf/atlas + hf/quandra assura/unify assura family of crt-d's | P030054/S226 | 04/10/2014 | Review | Approval |
merlin net 6.1m | P030054/S237 | 12/19/2012 | Review | Approval |
quadra assura/unify assura family of crt-ds | P030054/S238 | 06/06/2013 | Review | Approval |
quadra assura/unify assura family pf crt-ds | P030054/S254 | 02/26/2014 | Review | Approval |
quadra assura/unify assura family of crt-d's | P030054/S273 | 09/12/2014 | Review | Approval |
quadra assura / unify assura family of crt-d's | P030054/S284 | 08/27/2015 | Review | |
restylane l and perlane l injectable gels | P040024/S039 | 01/29/2010 | Review | Approval |
restylane injectable gel | P040024/S052 | 07/18/2011 | Review | Approval |
restylane/restylane-l/ perlane/ perlane-l , restylane silk(injectable gels) | P040024/S079 | 01/26/2016 | Review | |
juvederm ultra xc and juvederm ultra plus xc | P050047/S005 | 01/07/2010 | Review | Approval |
cellpaker plasma collection device | P050044/S019 | 01/31/2012 | Review | Approval |
vitagel surgical hemostat | P050044/S021 | 10/11/2013 | Review | |
kronos lv-t and lumax 300/340 & 500/540 hf/hf-t | P050023/S024 | 05/07/2010 | Review | Approval |
radiesse injectable implant | P050037/S024 | 10/31/2011 | Review | Approval |
radiesse injectable implant | P050052/S027 | 10/31/2011 | Review | Approval |
various models of lumax icd/crt-d families | P050023/S033 | 11/26/2010 | Review | Approval |
lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t | P050023/S039 | 04/15/2011 | Review | Approval |
lumax 300/340 vr-t/dr-t/hf-t/lumax 500/540 vr-t/dr-t/hf-t/lumax 540 vr-t dx | P050023/S046 | 09/30/2011 | Review | Approval |
lumax 500/540 icds thoracic impedance | P050023/S047 | 11/17/2011 | Review | Approval |
lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t | P050023/S048 | 05/04/2012 | Review | Approval |
kronos lv-t crt-d and lumax 300/340 & 500/540 crt-d's & icd's | P050023/S053 | 10/03/2012 | Review | Approval |
ilesto 7/ 5 vr-t icd, iforia 7/ 5 vr-t icd, ilesto 7/ 5 vr-t dx icd, ilforia 7/ 5 vr-t dx icd, ilesto 7/ 5 dr-t icd | P050023/S058 | 03/18/2013 | Review | Approval |
ilesto icd's and crt-d's | P050023/S074 | 05/04/2014 | Review | Approval |
ilesto/iforia 5/7 vrt/drt icd's, ilesto/iforia 5/7 hf-t crt-d | P050023/S076 | 07/03/2014 | Review | Approval |
iforia 7 dr-t (df-1 & df4), iperia 7 dr-t (df-1 & df-4), inventra 7 dr-t (df-1 & df-4) | P050023/S087 | 12/21/2015 | Review | |
paradym crt-d model 8750 | P060027/S015 | 04/07/2010 | Review | Approval |
model 4195 attain starfix lead | P060039/S021 | 11/22/2011 | Review | Approval |
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 | P060027/S026 | 09/09/2010 | Review | Approval |
paradym crt | P060027/S032 | 04/10/2012 | Approval | |
paradym rf crt-d | P060027/S038 | 05/09/2013 | Approval | |
memoryshape breast implants | P060028/S041 | 10/27/2021 | Approval | |
paradym rf:models vr 9250, dr 9550, crt-d 9750; paradym models vr 8250, dr 8550, crt-d 8750 | P060027/S053 | 03/06/2014 | Review | Approval |
attain starfix lead | P060039/S059 | 09/04/2014 | Review | Approval |
intensia crt-d | P060027/S066 | 11/04/2014 | Approval | |
evia/entovis pulse generators | P070008/S011 | 05/07/2010 | Review | Approval |
corox otw-l bp left ventricular pacing lead | P070008/S015 | 12/23/2010 | 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
-