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 |
---|---|---|---|---|
saline-filled and spectrum breast implants | P990075/S051 | 10/27/2021 | Approval | |
revo mri ipg | P090013/S165 | 10/19/2015 | Review | Approval |
revo mri ipg | P090013/S085 | 05/24/2013 | Review | Approval |
revo mri ipg | P090013/S107 | 09/27/2013 | Review | Approval |
revo mri ipg | P090013/S112 | 02/14/2014 | Review | Approval |
restylane/restylane-l/ perlane/ perlane-l , restylane silk(injectable gels) | P040024/S079 | 01/26/2016 | 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 |
reply/esprit sr and dr model pacemakers | P950029/S079 | 06/20/2013 | Review | Approval |
reocor s / d family of external pacemakers | P950037/S084 | 05/08/2012 | Review | Approval |
reliaty/model 3145 pacing system analyzer | P950037/S079 | 09/02/2010 | Review | Approval |
reliaty / model 3145 family of pacing system analyzers | P950037/S088 | 04/20/2011 | Review | Approval |
reliance 4-site defibrillator lead | P910073/S107 | 12/20/2012 | Review | Approval |
radiesse injectable implant | P050037/S024 | 10/31/2011 | Review | Approval |
radiesse injectable implant | P050052/S027 | 10/31/2011 | Review | Approval |
quickflex u model 1258t lead | P030054/S130 | 05/10/2010 | 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 |
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 | |
protego family of icd leads | P980023/S057 | 07/03/2014 | Review | Approval |
protects xt vr, protecta vr, secura vr maximo ii icd | P980016/S280 | 05/02/2012 | Review | Approval |
protecta xt crt-d and protecta crt-d implantable cardioverter defibrillators with cardiac resynchronization; model sw009 | P010031/S171 | 03/25/2011 | Review | Approval |
protecta df4 icd, protecta icd, protecta xt df4 icd, protecta xt icd | P980016/S361 | 09/10/2012 | Review | |
protecta crt-d, protecta df4 crt-d, protecta xt crt-d, protecta xt df4 crt-d | P010031/S314 | 09/10/2012 | Review | |
programmer software(1503.u) for ics 3000/renamic programmers | P000009/S063 | 12/21/2015 | Review | |
programmer software (1503.u) for the ics 3000/renamic programmers | P070008/S063 | 12/21/2015 | Review | |
paradym vr/dr | P980049/S065 | 04/10/2012 | Approval | |
paradym vr model 8250 & dr model 8550 | P980049/S050 | 04/07/2010 | Review | 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 |
paradym rf vr icds | P980049/S071 | 05/09/2013 | Approval | |
paradym rf crt-d | P060027/S038 | 05/09/2013 | Approval | |
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 | P060027/S026 | 09/09/2010 | Review | Approval |
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 | P980049/S059 | 09/09/2010 | Review | Approval |
paradym crt-d model 8750 | P060027/S015 | 04/07/2010 | Review | Approval |
paradym crt | P060027/S032 | 04/10/2012 | Approval | |
origen, inogen, and dynagen icd, incepta, energen, and punctua icd, teligen icd | P960040/S360 | 12/21/2015 | Review | |
origen, inogen, and dynagen crt-d, incepta energen punctua crt-d, cognis crt-d | P010012/S405 | 12/21/2015 | Review | |
optisense model 1999 lead | P960013/S057 | 11/26/2010 | Review | Approval |
natrelle silicone filled breast implants | P020056/S054 | 10/27/2021 | Approval | |
natrelle saline filled breast implants | P990074/S045 | 10/27/2021 | Approval | |
mycarelink patient monitor, device data management application, application software | P890003/S285 | 02/14/2014 | Review | Approval |
mycarelink patient monitor | P890003/S280 | 09/27/2013 | Review | Approval |
mycarelink patient monitor | P890003/S269 | 05/24/2013 | Review | Approval |
mycarelink monitor, | P890003/S295 | 02/27/2014 | Review | Approval |
model 5019 high voltage (hv) splitter/adaptor kit | P920015/S093 | 02/13/2013 | Review | Approval |
model 4195 attain starfix lead | P060039/S021 | 11/22/2011 | Review | Approval |
model 3140 zoom wireless transmitter and model 3120 zoom latitude programmer/recorder/monitor (prm) | P910077/S139 | 04/11/2014 | Review | Approval |
microny family pacemakers | P970013/S054 | 06/06/2013 | Review | Approval |
microny family of pacemakers | P970013/S050 | 04/10/2014 | 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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