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.
101 to 150 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
microny family of pacemakers | P970013/S044 | 05/07/2012 | Review | Approval |
microny family of pacemakers | P970013/S057 | 02/26/2014 | Review | Approval |
microny family of pacemakers | P970013/S060 | 09/12/2014 | Review | Approval |
microny family of pacemakers | P970013/S040 | 08/03/2011 | Review | Approval |
microny family of pacemakers | P970013/S034 | 03/04/2011 | Review | Approval |
microny family of pacemakers | P970013/S038 | 04/04/2011 | Review | Approval |
microny family of pacemakers | P970013/S064 | 08/27/2015 | Review | |
merlin net 6.1m | P030054/S237 | 12/19/2012 | Review | Approval |
merlin home 6.1m | P910023/S307 | 12/19/2012 | Review | Approval |
memoryshape breast implants | P060028/S041 | 10/27/2021 | Approval | |
memorygel/memorygel xtra breast implants | P030053/S062 | 10/27/2021 | Approval | |
medtronics carelink home monitor and cardiosight reader | P890003/S211 | 05/13/2011 | Review | Approval |
medtronics adapta, versa, sensia and relia implantable pulse generator | P980035/S150 | 12/08/2010 | Review | Approval |
medtronic sprint quattro secure lead model 6947m | P920015/S055 | 01/09/2012 | Review | Approval |
medtronic selectsecure lead model 3830 | P030036/S004 | 03/30/2011 | Review | Approval |
medtronic secura dr d204drm, maximo ii d264drm, implantable cardioverter defibrillators | P980016/S216 | 01/09/2012 | Review | Approval |
medtronic protecta xt dr d314drm, protecta dr d334drm, cardioverter defibrillators | P980016/S218 | 11/09/2011 | Review | Approval |
medtronic protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, implantable cardioverter defibrillators | P980016/S211 | 03/25/2011 | Review | Approval |
medtronic protecta xt crt-d d314trm and protecta crt-d d334 implantable cardioverter defibrillators | P010031/S178 | 11/09/2011 | Review | Approval |
medtronic pcd tachyarrhythmia control system | P920015/S146 | 10/19/2015 | Review | Approval |
medtronic gem icd,medtronic jewel icd,medtronic jewel plus icd,medtronic micro jewel icd,medtronic micro jewel ii icd,me | P900061/S133 | 10/19/2015 | Review | Approval |
medtronic evera xt dr, evera xt vr, evera s dr, evera s vr implantable cardioverter definrillators | P980016/S382 | 04/03/2013 | Review | Approval |
medtronic consulta crt-d d204trm, maximo ii crt-d d264trm implantable cardioverter defibrillators | P010031/S176 | 01/09/2012 | Review | Approval |
medtronic carelink programmer | P850051/S074 | 05/13/2011 | Review | Approval |
medtronic carelink monitor, cardiosight reader, carelink express | P890003/S259 | 04/03/2013 | Review | Approval |
medtronic carelink monitor, cardiosight reader | P890003/S214 | 05/02/2012 | Review | Approval |
medtronic carelink monitor model 2490c, cardiosight reader | P890003/S177 | 03/25/2011 | Review | Approval |
medtronic carelink monitor model 2490c, cardiosight reader | P890003/S181 | 11/09/2011 | 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 |
maximo ii, secura & virtuoso ii dr/vr icds | P980016/S343 | 06/04/2012 | Review | Approval |
maximo ii dr,maximo ii vr,virtuoso ii vr,secura dr,secura vr | P980016/S452 | 07/09/2014 | Review | Approval |
maximo ii df4 icd, secura df4 icd | P980016/S362 | 09/12/2012 | 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/S039 | 04/15/2011 | 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 |
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 |
linox(smart) s dx steroid-eluting single-coil icd leads | P980023/S049 | 02/13/2013 | Review | Approval |
linox smart(s65)(sd65/18)(sdx65/15&65/17),protego df-1(s65)(sd65/18)(dx65/15&65/17),protego(s65&75)(sd65/16,65/18,75/18) | P950037/S151 | 12/21/2015 | Review | |
linox smart steroid-eluting dual-coil icd leads | P980023/S038 | 09/17/2010 | Review | Approval |
linox smart s65,linox smart sd 65/18,linox s dx 65/15,linox s dx 65/17,protego df-1 s 65,protego df-1 sd 65/18,protego d | P980023/S072 | 12/21/2015 | Review | |
lifevest wearable defibrillator | P010030/S023 | 04/19/2011 | Review | Approval |
lifevest waerable defibrillator | P010030/S031 | 11/02/2012 | Review | Approval |
lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds | P000009/S046 | 09/30/2011 | Review | Approval |
legend plus ipg | P930022/S017 | 10/19/2015 | Review | Approval |
legend plus family of pacemakers | P930022/S012 | 05/13/2011 | Review | Approval |
lead tunneler model 6888 | P830060/S062 | 11/10/2010 | Review | Approval |
lattitude consult system | P910077/S138 | 03/20/2014 | Review | Approval |
latitude wave communicator (model 6498) | P910077/S119 | 01/28/2013 | Review | Approval |
latitude nxt 2.0 patient management system | P910077/S140 | 06/20/2014 | 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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