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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
ellipse/fortify assura family of icds P910023/S323 02/26/2014 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
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 P980016/S548 10/29/2015 Review  
evera mri xt dr, xt vr, s dr, s vr surescan icd's P980016/S536 09/11/2015 Review  
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
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 crt-p's P070008/S050 05/04/2014 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/S133 08/27/2015 Review  
frontier/ frontier ii / anthem family of crt-p's P030035/S123 09/12/2014 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/S115 02/26/2014 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S107 06/06/2013 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S089 05/07/2012 Review Approval
frontier/frontierii/anthem family of crt-ps P030035/S083 08/03/2011 Review Approval
gem iii at P980050/S076 10/26/2012 Review Approval
home monitoring system P950037/S019 10/11/2001   Approval
icd family of devices & fortify family of devices P910023/S295 08/09/2012 Review Approval
iforia 7 dr-t (df-1 & df4), iperia 7 dr-t (df-1 & df-4), inventra 7 dr-t (df-1 & df-4) P050023/S087 12/21/2015 Review  
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
ilesto icd's and crt-d's P050023/S074 05/04/2014 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
 
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