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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
adapta,versa,sensia ipg,advisa dr ipg,advisa dr mri ipg,at500 dddrp pacing system ipg, enpulse e2 ipg,enpulse e2 ipg,kap P980035/S404 10/19/2015 Review Approval
elite,elite ii,minuet,preva,prodigy,thera d,thera dr ipgs, thera id pg,thera ipg,thera s ipg,thera sr ipg,thera vdd ipg, P890003/S326 10/19/2015 Review Approval
consulta,syncra,viva crt-ps,insync ipg P010015/S255 10/19/2015 Review Approval
brava,brava quad,concerto ii,consulta,maximo ii,protecta,protecta xt,viva quad s, viva quad xt,viva s, viva xt crt-ds, c P010031/S478 10/19/2015 Review Approval
revo mri ipg P090013/S165 10/19/2015 Review Approval
symbios,synergyst ipgs P820003/S132 10/19/2015 Review Approval
activitrax ii ipg,activitrax ipg,legend ii ipg,legend ipg,micro minix ipg,minix ipg,minix st ipg,premier ipg,prevail ipg P850051/S082 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 pcd tachyarrhythmia control system P920015/S146 10/19/2015 Review Approval
legend plus ipg P930022/S017 10/19/2015 Review Approval
kappa 400 dr ipg,kappa 400 sr ipg P970012/S096 10/19/2015 Review Approval
evera s dr icd, evera s vr icd,evera xt dr icd, evera xt vr icd,gem dr icd,gem ii dr icd, gem ii vr icd,gem iii vr icd,i P980016/S514 10/19/2015 Review Approval
jewel af icd P980050/S097 10/19/2015 Review Approval
vitatron c20 sr ipg,vitatron c60 dr ipg,vitatron t20 sr ipg,vitatron t60 dr ipg P990001/S119 10/19/2015 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
celerity 2d/3d/pilot steroid-eluting lv lead, corox (-s/-l) bp steroid-eluting lv lead P070008/S054 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
ellipse / fortify assura family of icd's P910023/S342 09/12/2014 Review Approval
quadra assura/unify assura family of crt-d's P030054/S273 09/12/2014 Review Approval
frontier/ frontier ii / anthem family of crt-p's P030035/S123 09/12/2014 Review Approval
microny family of pacemakers P970013/S060 09/12/2014 Review Approval
affinity, integrity, victory, zephyr, & accent family of pacemakers P880086/S245 09/12/2014 Review Approval
sensolog/ dialog/regency family of pacemakers P880006/S089 09/12/2014 Review Approval
attain starfix lead P060039/S059 09/04/2014 Review Approval
subcutaneous implantable defibrillator (s-icd) system P110042/S029 08/22/2014 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
advisa dr,advisa dr mri P980035/S358 07/09/2014 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 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
latitude nxt 2.0 patient management system P910077/S140 06/20/2014 Review Approval
attain ability model 4x96 lead P080006/S063 05/15/2014 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
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
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
dynagen el & mini icd's; inogen el & mini icd's; origen el & mini icd's; teligen icd P960040/S306 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
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
lattitude consult system P910077/S138 03/20/2014 Review Approval
 
 
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