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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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cognis 4-site models P010012/S212 11/10/2010 Review Approval
cognis, incepta, energen and punctua crt-d devices P010012/S300 11/30/2012 Review Approval
concert ii, consulta, & maximo ii crt-ds P010031/S296 06/04/2012 Review Approval
concerta, consulta/consulta df4, & various insync families of icd's; concerto ii, maximo ii,protecta,protecta xt crt-d's P010031/S329 10/26/2012 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
concerto ii/consulta/insync ii marquis/iii marquis/insync maximo/sentry/maximo ii/protecta/protecta xt P010031/S252 08/18/2011 Review Approval
concerto ii/consulta/maximo ii crt-ds P010031/S198 03/22/2011 Review Approval
concerto ii/maximo ii/consulta crt-ds P010031/S228 05/13/2011 Review Approval
concerto, virtuoso (model sw002 v8.0) P980016/S366 03/13/2013 Review Approval
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
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
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 icd's P910023/S342 09/12/2014 Review Approval
ellipse/fortify assura family of icds P910023/S309 06/06/2013 Review Approval
ellipse/fortify assura family of icds P910023/S323 02/26/2014 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
entovis promri pacemaker system P950037/S132 05/04/2014 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