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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
consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization P010015/S084 03/22/2011 Review Approval
consulta crt-d/concerto ii crt-d/maximo crt-d icds P010031/S150 04/04/2011 Review Approval
consulta crt-p, advisa (model 9995 v8.0) consulta crt-d, secura (model 9995 v8.0) insync iii, maximo ii, concerto ii P010031/S319 03/13/2013 Review Approval
consulta crt-p, syncra crt-p P010015/S215 02/14/2014 Review Approval
consulta crt-p, syncra crt-p P010015/S157 06/04/2012 Review Approval
consulta crt-p, syncra crt-p P010015/S190 05/24/2013 Review Approval
consulta crt-p,syncra crt-p P010015/S208 09/27/2013 Review Approval
corox otw-l bp leads P070008/S026 09/30/2011 Review Approval
corox otw-l bp left ventricular pacing lead P070008/S015 12/23/2010 Review Approval
cylos/dr/dr-t/vr/dromos dr/sr/sl/kairos dr/sr/sl/d/s/philos/dr/dr-t/sr/slr/d/s/philos ii d/dr/s/slr/sr/dr-t/protos dr/cl P950037/S100 05/04/2012 Review Approval
ddma software P890003/S251 09/12/2012 Review Approval
dema ipg/c & t series ipgs P990001/S082 05/13/2011 Review Approval
dema ipg/c & t series ipgs P990001/S068 03/22/2011 Review Approval
device carelink encore 29901 programmer including accessories and reveal dx, reveal xt (model sw007 v8.0) P890003/S254 03/13/2013 Review Approval
dual chamber, implantable pulse generator P820003/S104 05/13/2011 Review Approval
durata family of leads P950022/S069 01/24/2011 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
ellipse/fortify assura family of icds P910023/S309 06/06/2013 Review Approval
endotak reliance 4-site leads and accessories P910073/S077 11/10/2010 Review Approval
endotak reliance is-i passive fixation P910073/S091 01/05/2012 Review Approval
enrythm ipg P980016/S237 10/19/2010 Review Approval
entrust icd family P980035/S166 10/19/2010 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, 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
entrust,intrinsic 30,intrinsic,marquis dr,marquis vr,maximo dr,maximo vr icds P980016/S425 09/27/2013 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/marquis/maximo/ii/protecta xt/icd/secura/virtuoso ii P980016/S298 08/18/2011 Review Approval
epic hf crt-d system P030054/S131 01/29/2010 Review Approval
epic hf/atlas + hf family P030054/S196 03/09/2012 Review Approval
epic hf/atlas + hf family of crt-ds P030054/S189 08/03/2011 Review Approval
epic hf/atlas + hf/quandra assura/unify assura family of crt-d's P030054/S226 04/10/2014 Review Approval
epic hf/atlas+hf hamily of crt-ds P030054/S177 04/04/2011 Review Approval
epic hf/atlas+hf/promote/unify families of crt-ds P030054/S181 06/21/2011 Review Approval
epic hf/atlas+hf/quadra assura/unify assura family of crt-ds P030054/S206 05/07/2012 Review Approval
epic hr/atlas + hf family of crt-ds P030054/S153 03/04/2011 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
evia / entovis & various other pulse generators P950037/S072 05/07/2010 Review Approval
evia / entovis family of pulse generators P950037/S091 03/25/2011 Review Approval
evia/entovis dr/dr-t/sr-t & various other models of pulse generators P950037/S083 11/26/2010 Review Approval
evia/entovis pulse generators P000009/S035 05/07/2010 Review Approval
evia/entovis pulse generators P070008/S011 05/07/2010 Review Approval
evia/entovis/estella/effecta/ecuro P950037/S098 09/30/2011 Review Approval
fineline ii sterox lead P960004/S060 09/09/2013 Review Approval
floseal hemostatic matrix 5 ml/10 ml kit P990009/S025 01/07/2010 Review Approval
fortify dr / vr icd systems P910023/S226 05/07/2010 Review Approval
frontier/ frontier ii /anthem family of crt-p's P030035/S098 04/10/2014 Review Approval
frontier/frontier 2 family of crt-ps P030035/S070 03/04/2011 Review Approval
frontier/frontier ii family of crt-ps P030035/S075 04/04/2011 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S089 05/07/2012 Review Approval
 
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