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.
151 to 200 of 325 records |
|
Device
Name |
PMA
Number |
Decision
Date |
Review Memo |
Approval Order |
---|---|---|---|---|
kronos lv-t crt-d and lumax 300/340 & 500/540 crt-d's & icd's | P050023/S053 | 10/03/2012 | Review | Approval |
kronos lv-t and lumax 300/340 & 500/540 hf/hf-t | P050023/S024 | 05/07/2010 | Review | Approval |
kappa 900 (model 9988 v8.0). adapta, versa, sensia (model sw003 v8.0), relia (model sw010 v8.0), enpulse (model 9981 v8. | P980035/S280 | 03/13/2013 | Review | Approval |
kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/sensia ipgs | P980035/S200 | 05/13/2011 | Review | Approval |
kappa 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/senia ipgs | P980035/S168 | 03/22/2011 | Review | Approval |
kappa 400 dr/sr ipgs | P970012/S081 | 05/13/2011 | Review | Approval |
kappa 400 dr/sr ipg | P970012/S068 | 03/22/2011 | Review | Approval |
kappa 400 dr ipg,kappa 400 sr ipg | P970012/S096 | 10/19/2015 | Review | Approval |
juvederm ultra xc and juvederm ultra plus xc | P050047/S005 | 01/07/2010 | Review | Approval |
jewel af icd | P980050/S097 | 10/19/2015 | Review | Approval |
invive v172, v173 | P030005/S079 | 05/01/2012 | Review | Approval |
intua cardiac resynchronization therapy-pacemaker (crt-p) | P030005/S092 | 05/23/2013 | Review | Approval |
intensia crt-d | P060027/S066 | 11/04/2014 | Approval | |
integrity afx dr model 5346 dual chamber pulse generator and programmer software model 3307, v2.2a | P880086/S083 | 07/11/2001 | Approval | |
insync iii (model 9981 v8.0) | P010015/S166 | 03/13/2013 | Review | Approval |
insync ii protect, insync iii marquis,insync marquis, insync maximo icds | P010031/S386 | 09/27/2013 | Review | Approval |
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 p rotect icd, insync iii marquis icd, insync marquis icd, insync maximo icd | P010031/S363 | 05/24/2013 | Review | Approval |
insync crt-p/insync iii crt-p | P010015/S107 | 05/13/2011 | Review | Approval |
insync crt-p & insync iii crt-p | P010015/S086 | 03/22/2011 | Review | Approval |
instensia icd | P980049/S099 | 11/04/2014 | Approval | |
incepta, energen, punctua and teligen icds | P960040/S235 | 11/17/2011 | Review | Approval |
incepta, energen, punctua and cognis crt-d | P010012/S255 | 11/17/2011 | Review | Approval |
implantable pacemaker pulse generator,pacemaker programming | P950037/S089 | 04/15/2011 | Review | Approval |
implantable cv defibrillator/pacemaker programmer/icd monitoring system | P000009/S042 | 04/15/2011 | 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 |
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 |
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 | |
icd family of devices & fortify family of devices | P910023/S295 | 08/09/2012 | Review | Approval |
home monitoring system | P950037/S019 | 10/11/2001 | Approval | |
gem iii at | P980050/S076 | 10/26/2012 | Review | Approval |
frontier/frontierii/anthem family of crt-ps | P030035/S083 | 08/03/2011 | Review | Approval |
frontier/frontier ii/anthem family of crt-ps | P030035/S107 | 06/06/2013 | Review | Approval |
frontier/frontier ii/anthem family of crt-ps | P030035/S089 | 05/07/2012 | Review | Approval |
frontier/frontier ii/ anthem family of crt-ps | P030035/S115 | 02/26/2014 | 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 |
frontier/ frontier ii /anthem family of crt-p's | P030035/S098 | 04/10/2014 | 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-p's | P030035/S133 | 08/27/2015 | Review | |
fortify dr / vr icd systems | P910023/S226 | 05/07/2010 | Review | Approval |
floseal hemostatic matrix 5 ml/10 ml kit | P990009/S025 | 01/07/2010 | Review | Approval |
fineline ii sterox lead | P960004/S060 | 09/09/2013 | Review | Approval |
evia/entovis/estella/effecta/ecuro | P950037/S098 | 09/30/2011 | Review | Approval |
evia/entovis pulse generators | P000009/S035 | 05/07/2010 | Review | Approval |
evia/entovis pulse generators | P070008/S011 | 05/07/2010 | Review | Approval |
evia/entovis dr/dr-t/sr-t & various other models of pulse generators | P950037/S083 | 11/26/2010 | Review | Approval |
evia crt-p's | P070008/S050 | 05/04/2014 | Review | Approval |
evia / entovis family of pulse generators | P950037/S091 | 03/25/2011 | 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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