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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
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
advisa dr,advisa dr mri P980035/S358 07/09/2014 Review Approval
subcutaneous implantable defibrillator (s-icd) system P110042/S029 08/22/2014 Review Approval
attain starfix lead P060039/S059 09/04/2014 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
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
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
intensia crt-d P060027/S066 11/04/2014   Approval
instensia icd P980049/S099 11/04/2014   Approval
attain performa model 4398 and 4598 left ventricular leads P080006/S073 12/10/2014 Review  
capsurefix novus mri surescan lead model 5076 P930039/S130 06/22/2015 Review  
advisa sr ipg P980035/S424 06/22/2015 Review  
cardiomems hf pressure measurement system P100045/S002 07/10/2015 Review  
ellipse/fortify assura family of icd's P910023/S355 08/27/2015 Review  
quadra assura / unify assura family of crt-d's P030054/S284 08/27/2015 Review  
frontier / frontier ii / anthem family of crt-p's P030035/S133 08/27/2015 Review  
microny family of pacemakers P970013/S064 08/27/2015 Review  
affinity/integrity / victory /zephyr accent family of pacemakers P880086/S255 08/27/2015 Review  
sensolog / dialog/ regency family of pacemakers P880006/S093 08/27/2015 Review  
evera mri xt dr, xt vr, s dr, s vr surescan icd's P980016/S536 09/11/2015 Review  
sprint quattro secure s mri surescan and sprint quattro secure mri surescan P920015/S151 09/11/2015 Review  
carelink monitor and express monitor, cardiosight reader; carelink express P890003/S329 09/11/2015 Review  
5076 capsurefix novus surescan leads P930039/S138 09/11/2015 Review  
5086 mri capsurefix mri surescan leads P090013/S200 09/11/2015 Review  
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
 
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