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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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Review
Memo
Approval
Order
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
consulta crt-p, syncra crt-p P010015/S215 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
revo mri ipg P090013/S112 02/14/2014 Review Approval
mycarelink patient monitor, device data management application, application software P890003/S285 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
capsure sense lead P830061/S086 02/18/2014 Review Approval
ellipse/fortify assura family of icds P910023/S323 02/26/2014 Review Approval
microny family of pacemakers P970013/S057 02/26/2014 Review Approval
frontier/frontier ii/ anthem family of crt-ps P030035/S115 02/26/2014 Review Approval
quadra assura/unify assura family pf crt-ds P030054/S254 02/26/2014 Review Approval
sensolog/dialog/ regency family of pacemakers P880006/S087 02/26/2014 Review Approval
affinity/ integrity/ victory/ zephyr/accent family of pacemakers P880086/S237 02/26/2014 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
brava crt-d,viva s crt-d,viva xt crt-d,viva/brava/evera programmer application software P010031/S413 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
frontier/ frontier ii /anthem family of crt-p's P030035/S098 04/10/2014 Review Approval
epic hf/atlas + hf/quandra assura/unify assura family of crt-d's P030054/S226 04/10/2014 Review Approval
sensolog/ dialog/regency family of pacemakers P880006/S081 04/10/2014 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S220 04/10/2014 Review Approval
cadence/ellipse/fortify assura family of icd's P910023/S297 04/10/2014 Review Approval
microny family of pacemakers P970013/S050 04/10/2014 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
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
attain ability model 4x96 lead P080006/S063 05/15/2014 Review Approval
attain starfix lead P060039/S059 09/04/2014 Review Approval
frontier/ frontier ii / anthem family of crt-p's P030035/S123 09/12/2014 Review Approval
quadra assura/unify assura family of crt-d's P030054/S273 09/12/2014 Review Approval
sensolog/ dialog/regency family of pacemakers P880006/S089 09/12/2014 Review Approval
affinity, integrity, victory, zephyr, & accent family of pacemakers P880086/S245 09/12/2014 Review Approval
ellipse / fortify assura family of icd's P910023/S342 09/12/2014 Review Approval
microny family of pacemakers P970013/S060 09/12/2014 Review Approval
celerity 2d/3d/pilot steroid-eluting lv lead, corox (-s/-l) bp steroid-eluting lv lead P070008/S054 09/16/2014 Review Approval
dextrus, selox st/jt, setrox s, and tilda t/jt/r steroid-eluting pacing leads; solox slx -bp pacing lead P950037/S138 09/16/2014 Review Approval
volta(1cr/2cr/ct/2ct) icd lead, protego (s/sd/t/td) icd lead,kainox vcs 60 icd leadlinox smart (s/sd/t/td/s dx) icd lead P980023/S060 09/16/2014 Review Approval
 
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