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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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Device
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PMA
Number
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Decision
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Review
Memo
Approval
Order
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 600/700/650/800/900/relia/sigma/medtronic 350/enpulse/enrhythm/at500/adapta/versa/senia ipgs P980035/S168 03/22/2011 Review Approval
kappa 400 dr/sr ipgs P970012/S081 05/13/2011 Review Approval
kappa 400 dr/sr ipg P970012/S068 03/22/2011 Review Approval
juvederm ultra xc and juvederm ultra plus xc P050047/S005 01/07/2010 Review Approval
invive v172, v173 P030005/S079 05/01/2012 Review Approval
intua cardiac resynchronization therapy-pacemaker (crt-p) P030005/S092 05/23/2013 Review Approval
insync iii (model 9981 v8.0) P010015/S166 03/13/2013 Review Approval
insync ii protect, insync iii marquis,insync marquis, insync maximo icds P010031/S386 09/27/2013 Review Approval
insync ii p rotect icd, insync iii marquis icd, insync marquis icd, insync maximo icd P010031/S363 05/24/2013 Review Approval
insync crt-p/insync iii crt-p P010015/S107 05/13/2011 Review Approval
insync crt-p & insync iii crt-p P010015/S086 03/22/2011 Review Approval
incepta, energen, punctua and teligen icds P960040/S235 11/17/2011 Review Approval
incepta, energen, punctua and cognis crt-d P010012/S255 11/17/2011 Review Approval
implantable pacemaker pulse generator,pacemaker programming P950037/S089 04/15/2011 Review Approval
implantable cv defibrillator/pacemaker programmer/icd monitoring system P000009/S042 04/15/2011 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
icd family of devices & fortify family of devices P910023/S295 08/09/2012 Review Approval
gem iii at P980050/S076 10/26/2012 Review Approval
frontier/frontierii/anthem family of crt-ps P030035/S083 08/03/2011 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S089 05/07/2012 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S107 06/06/2013 Review Approval
frontier/frontier ii family of crt-ps P030035/S075 04/04/2011 Review Approval
frontier/frontier 2 family of crt-ps P030035/S070 03/04/2011 Review Approval
fortify dr / vr icd systems P910023/S226 05/07/2010 Review Approval
floseal hemostatic matrix 5 ml/10 ml kit P990009/S025 01/07/2010 Review Approval
fineline ii sterox lead P960004/S060 09/09/2013 Review Approval
evia/entovis/estella/effecta/ecuro P950037/S098 09/30/2011 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 dr/dr-t/sr-t & various other models of pulse generators P950037/S083 11/26/2010 Review Approval
evia / entovis family of pulse generators P950037/S091 03/25/2011 Review Approval
evia / entovis & various other pulse generators P950037/S072 05/07/2010 Review Approval
epic hr/atlas + hf family of crt-ds P030054/S153 03/04/2011 Review Approval
epic hf/atlas+hf/quadra assura/unify assura family of crt-ds P030054/S206 05/07/2012 Review Approval
epic hf/atlas+hf/promote/unify families of crt-ds P030054/S181 06/21/2011 Review Approval
epic hf/atlas+hf hamily of crt-ds P030054/S177 04/04/2011 Review Approval
epic hf/atlas + hf family of crt-ds P030054/S189 08/03/2011 Review Approval
epic hf/atlas + hf family P030054/S196 03/09/2012 Review Approval
epic hf crt-d system P030054/S131 01/29/2010 Review Approval
entrust/intrinsic/marquis/maximo/ii/protecta xt/icd/secura/virtuoso ii P980016/S298 08/18/2011 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 30,intrinsic,marquis dr,marquis vr,maximo dr,maximo vr icds P980016/S425 09/27/2013 Review Approval
entrust icd, intrinsic 30 icd, intrinsic icd, intrinsic icd, marquis dr icd, marquis vr icd, maximo dr icd, maximo vr ic P980016/S400 05/24/2013 Review Approval
entrust icd family P980035/S166 10/19/2010 Review Approval
enrythm ipg P980016/S237 10/19/2010 Review Approval
endotak reliance is-i passive fixation P910073/S091 01/05/2012 Review Approval
endotak reliance 4-site leads and accessories P910073/S077 11/10/2010 Review Approval
ellipse/fortify assura family of icds P910023/S309 06/06/2013 Review Approval
durata family of leads P950022/S069 01/24/2011 Review Approval
 
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