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U.S. Department of Health and Human Services

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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subcutaneous implantable defibrillator (s-icd) system P110042/S009 08/28/2013 Review Approval
carelink programmer model 2090 and model 9790/c programmer P890003/S260 09/05/2013 Review Approval
fineline ii sterox lead P960004/S060 09/09/2013 Review Approval
mycarelink patient monitor P890003/S280 09/27/2013 Review Approval
entrust,intrinsic 30,intrinsic,marquis dr,marquis vr,maximo dr,maximo vr icds P980016/S425 09/27/2013 Review Approval
adapta,versa,sensia,advisa dr,advisa dr mri,enpulse e1,enpulse e2,enrhythm,kappa d(kappa 700),kappa d (kappa 900) ipg, k P980035/S338 09/27/2013 Review Approval
consulta crt-p,syncra crt-p P010015/S208 09/27/2013 Review Approval
insync ii protect, insync iii marquis,insync marquis, insync maximo icds P010031/S386 09/27/2013 Review Approval
revo mri ipg P090013/S107 09/27/2013 Review Approval
mycarelink patient monitor, device data management application, application software P890003/S285 02/14/2014 Review Approval
consulta crt-p, syncra crt-p P010015/S215 02/14/2014 Review Approval
revo mri ipg P090013/S112 02/14/2014 Review Approval
entrust icd, intrinsic 30icd, marquis dr icd, vr icd, maximo dr icd, vr icd, evera s dr icd, s vr icd,xt vr icd, maximo P980016/S436 02/14/2014 Review Approval
adapta, versa, sensia ipg, advisa dr ipg, dr mri ipg, enpulse el ipg, e2 ipg, enrhythm ipg, kappa d ipg P980035/S343 02/14/2014 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
capsure sense lead P830061/S086 02/18/2014 Review Approval
ellipse/fortify assura family of icds P910023/S323 02/26/2014 Review Approval
quadra assura/unify assura family pf crt-ds P030054/S254 02/26/2014 Review Approval
frontier/frontier ii/ anthem family of crt-ps P030035/S115 02/26/2014 Review Approval
microny family of pacemakers P970013/S057 02/26/2014 Review Approval
affinity/ integrity/ victory/ zephyr/accent family of pacemakers P880086/S237 02/26/2014 Review Approval
sensolog/dialog/ regency family of pacemakers P880006/S087 02/26/2014 Review Approval
brava crt-d,viva s crt-d,viva xt crt-d,viva/brava/evera programmer application software P010031/S413 02/27/2014 Review Approval
evera s dr icd,evera s vr icd, evera xt dr icd,evera xt vr icd, viva/brava/evera programmer application software P980016/S451 02/27/2014 Review Approval
mycarelink monitor, P890003/S295 02/27/2014 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
lattitude consult system P910077/S138 03/20/2014 Review Approval
epic hf/atlas + hf/quandra assura/unify assura family of crt-d's P030054/S226 04/10/2014 Review Approval
cadence/ellipse/fortify assura family of icd's P910023/S297 04/10/2014 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S220 04/10/2014 Review Approval
frontier/ frontier ii /anthem family of crt-p's P030035/S098 04/10/2014 Review Approval
sensolog/ dialog/regency family of pacemakers P880006/S081 04/10/2014 Review Approval
microny family of pacemakers P970013/S050 04/10/2014 Review Approval
model 3140 zoom wireless transmitter and model 3120 zoom latitude programmer/recorder/monitor (prm) P910077/S139 04/11/2014 Review Approval
dynagen el & mini icd's; inogen el & mini icd's; origen el & mini icd's; teligen icd P960040/S306 04/11/2014 Review Approval
dynagen & dynagen x4 crt-d's; inogen & inogen x4 crt-d's; origen & origen x4 crt-d's; cognis crt-d P010012/S341 04/11/2014 Review Approval
entovis promri pacemaker system P950037/S132 05/04/2014 Review Approval
ilesto icd's and crt-d's P050023/S074 05/04/2014 Review Approval
evia crt-p's P070008/S050 05/04/2014 Review Approval
xelos dr-t icd's P000009/S057 05/04/2014 Review Approval
attain ability model 4x96 lead P080006/S063 05/15/2014 Review Approval
latitude nxt 2.0 patient management system P910077/S140 06/20/2014 Review Approval
viva quad xt crt-d,viva quad s crt-d,brava quad crt-d,viva quad c crt-d,viva/brava/evera software application P010031/S442 07/03/2014 Review Approval
carelink monitor,cardiosight reader,carelink express,device data management application(ddma) P890003/S309 07/03/2014 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
protego family of icd leads P980023/S057 07/03/2014 Review Approval
viva crt-p,consulta crt-p,syncra crt-p P010015/S227 07/09/2014 Review Approval
carelink enore programmer,carelink 2090 programmer,carelink home monitor,carelink express monitor,cardiosight reader,dev P890003/S297 07/09/2014 Review Approval
concerto ii crt-d,maximo ii crt-d,consulta crt-d,consulta crt-d df4,maximo ii crt-d df4 P010031/S414 07/09/2014 Review Approval
maximo ii dr,maximo ii vr,virtuoso ii vr,secura dr,secura vr P980016/S452 07/09/2014 Review Approval