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.
1 to 50 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
subcutaneous implantable defibrillator (s-icd) system | P110042/S029 | 08/22/2014 | Review | Approval |
subcutaneous implantable defibrillator (s-icd) system | P110042/S009 | 08/28/2013 | Review | Approval |
cameron health subcutaneous implantable defibrillator s-icd system | P110042/S002 | 03/07/2013 | Review | Approval |
cardiomems hf pressure measurement system | P100045/S002 | 07/10/2015 | Review | |
capsurefix mri surescan | P090013/S202 | 02/01/2016 | Review | |
5086 mri capsurefix mri surescan leads | P090013/S200 | 09/11/2015 | Review | |
revo mri ipg | P090013/S165 | 10/19/2015 | Review | Approval |
revo mri ipg | P090013/S112 | 02/14/2014 | Review | Approval |
revo mri ipg | P090013/S107 | 09/27/2013 | Review | Approval |
revo mri ipg | P090013/S085 | 05/24/2013 | Review | Approval |
attain ability mri , plus mri,straight mri surescan; attain performa mri, straight ans s mri surescan | P080006/S085 | 02/01/2016 | Review | |
attain performa model 4398 and 4598 left ventricular leads | P080006/S073 | 12/10/2014 | Review | |
attain ability model 4x96 lead | P080006/S063 | 05/15/2014 | Review | Approval |
medtronic attain ability straight model 4396 left ventricular lead | P080006/S004 | 03/31/2011 | Review | Approval |
medtronic attain ability plus model 4296 lead | P080006/S002 | 04/01/2011 | Review | Approval |
programmer software (1503.u) for the ics 3000/renamic programmers | P070008/S063 | 12/21/2015 | Review | |
celerity 2d/3d/pilot steroid-eluting lv lead, corox (-s/-l) bp steroid-eluting lv lead | P070008/S054 | 09/16/2014 | Review | Approval |
evia crt-p's | P070008/S050 | 05/04/2014 | Review | Approval |
stratos lv/lv-t, evia and entovis hf/hf-t crt-p's | P070008/S036 | 03/18/2013 | Review | Approval |
sientra opus silicone gel breast implants | P070004/S033 | 10/27/2021 | Approval | |
stratos lv/lv-t | P070008/S031 | 10/03/2012 | Review | Approval |
stratos lv/lv-t | P070008/S028 | 05/04/2012 | Review | Approval |
corox otw-l bp leads | P070008/S026 | 09/30/2011 | Review | Approval |
stratos lv/lv-t | P070008/S019 | 04/15/2011 | Review | Approval |
stratos lv/lv-t crt-p | P070008/S017 | 11/26/2010 | Review | Approval |
corox otw-l bp left ventricular pacing lead | P070008/S015 | 12/23/2010 | Review | Approval |
evia/entovis pulse generators | P070008/S011 | 05/07/2010 | Review | Approval |
intensia crt-d | P060027/S066 | 11/04/2014 | Approval | |
attain starfix lead | P060039/S059 | 09/04/2014 | 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 |
memoryshape breast implants | P060028/S041 | 10/27/2021 | Approval | |
paradym rf crt-d | P060027/S038 | 05/09/2013 | Approval | |
paradym crt | P060027/S032 | 04/10/2012 | Approval | |
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 | P060027/S026 | 09/09/2010 | Review | Approval |
model 4195 attain starfix lead | P060039/S021 | 11/22/2011 | Review | Approval |
paradym crt-d model 8750 | P060027/S015 | 04/07/2010 | 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 | |
ilesto/iforia 5/7 vrt/drt icd's, ilesto/iforia 5/7 hf-t crt-d | P050023/S076 | 07/03/2014 | Review | Approval |
ilesto icd's and crt-d's | P050023/S074 | 05/04/2014 | 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 |
kronos lv-t crt-d and lumax 300/340 & 500/540 crt-d's & icd's | P050023/S053 | 10/03/2012 | 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 |
lumax 500/540 icds thoracic impedance | P050023/S047 | 11/17/2011 | 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 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 |
various models of lumax icd/crt-d families | P050023/S033 | 11/26/2010 | Review | Approval |
radiesse injectable implant | P050052/S027 | 10/31/2011 | Review | Approval |
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 |
vitagel surgical hemostat | P050044/S021 | 10/11/2013 | Review |
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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