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.
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Device
Name ![Sort by Device Name [A-Z]](/scripts/cdrh/images/arrow_up-black.GIF){kind=icon} ![Sort by Device Name [Z-A]](/scripts/cdrh/images/arrow_down-black.GIF){kind=icon}
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PMA
Number
|
Decision
Date
|
Review Memo |
Approval Order |
|---|---|---|---|---|
| dema ipg/c & t series ipgs | P990001/S068 | 03/22/2011 | Review | Approval |
| device carelink encore 29901 programmer including accessories and reveal dx, reveal xt (model sw007 v8.0) | P890003/S254 | 03/13/2013 | Review | Approval |
| dual chamber, implantable pulse generator | P820003/S104 | 05/13/2011 | Review | Approval |
| durata family of leads | P950022/S069 | 01/24/2011 | Review | Approval |
| endotak reliance 4-site leads and accessories | P910073/S077 | 11/10/2010 | Review | Approval |
| endotak reliance is-i passive fixation | P910073/S091 | 01/05/2012 | Review | Approval |
| enrythm ipg | P980016/S237 | 10/19/2010 | Review | Approval |
| entrust icd family | P980035/S166 | 10/19/2010 | Review | Approval |
| entrust,secura,gem ii/iii vr/dr,intrinsic/intrinsic 30,maximo vr/dr,maximo ii,marquis vr/dr,protecta/protecta xt | P980016/S376 | 10/26/2012 | Review | Approval |
| entrust/intrinsic/marquis/maximo/ii/protecta xt/icd/secura/virtuoso ii | P980016/S298 | 08/18/2011 | Review | Approval |
| epic hf crt-d system | P030054/S131 | 01/29/2010 | Review | Approval |
| epic hf/atlas + hf family | P030054/S196 | 03/09/2012 | Review | Approval |
| epic hf/atlas + hf family of crt-ds | P030054/S189 | 08/03/2011 | 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 |
| epic hf/atlas+hf/quadra assura/unify assura family of crt-ds | P030054/S206 | 05/07/2012 | Review | Approval |
| epic hr/atlas + hf family of crt-ds | P030054/S153 | 03/04/2011 | Review | Approval |
| evia / entovis & various other pulse generators | P950037/S072 | 05/07/2010 | Review | Approval |
| evia / entovis family of pulse generators | P950037/S091 | 03/25/2011 | Review | Approval |
| evia/entovis dr/dr-t/sr-t & various other models of pulse generators | P950037/S083 | 11/26/2010 | Review | Approval |
| evia/entovis pulse generators | P070008/S011 | 05/07/2010 | Review | Approval |
| evia/entovis pulse generators | P000009/S035 | 05/07/2010 | Review | Approval |
| evia/entovis/estella/effecta/ecuro | P950037/S098 | 09/30/2011 | Review | Approval |
| floseal hemostatic matrix 5 ml/10 ml kit | P990009/S025 | 01/07/2010 | Review | Approval |
| fortify dr / vr icd systems | P910023/S226 | 05/07/2010 | Review | Approval |
| frontier/frontier 2 family of crt-ps | P030035/S070 | 03/04/2011 | Review | Approval |
| frontier/frontier ii family of crt-ps | P030035/S075 | 04/04/2011 | Review | Approval |
| frontier/frontier ii/anthem family of crt-ps | P030035/S089 | 05/07/2012 | Review | Approval |
| frontier/frontierii/anthem family of crt-ps | P030035/S083 | 08/03/2011 | Review | Approval |
| gem iii at | P980050/S076 | 10/26/2012 | Review | Approval |
| icd family of devices & fortify family of devices | P910023/S295 | 08/09/2012 | 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 |
| implantable cv defibrillator/pacemaker programmer/icd monitoring system | P000009/S042 | 04/15/2011 | Review | Approval |
| implantable pacemaker pulse generator,pacemaker programming | P950037/S089 | 04/15/2011 | Review | Approval |
| incepta, energen, punctua and cognis crt-d | P010012/S255 | 11/17/2011 | Review | Approval |
| incepta, energen, punctua and teligen icds | P960040/S235 | 11/17/2011 | Review | Approval |
| insync crt-p & insync iii crt-p | P010015/S086 | 03/22/2011 | Review | Approval |
| insync crt-p/insync iii crt-p | P010015/S107 | 05/13/2011 | Review | Approval |
| insync iii (model 9981 v8.0) | P010015/S166 | 03/13/2013 | Review | Approval |
| invive v172, v173 | P030005/S079 | 05/01/2012 | Review | Approval |
| juvederm ultra xc and juvederm ultra plus xc | P050047/S005 | 01/07/2010 | Review | Approval |
| kappa 400 dr/sr ipg | P970012/S068 | 03/22/2011 | Review | Approval |
| kappa 400 dr/sr ipgs | P970012/S081 | 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 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/sensia ipgs | P980035/S200 | 05/13/2011 | 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 |
| kronos lv-t and lumax 300/340 & 500/540 hf/hf-t | P050023/S024 | 05/07/2010 | 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 |
| latitude wave communicator (model 6498) | P910077/S119 | 01/28/2013 | Review | Approval |
| lead tunneler model 6888 | P830060/S062 | 11/10/2010 | Review | Approval |
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