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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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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
adapta,versa,sensia ipg,advisa dr ipg,advisa dr mri ipg,at500 dddrp pacing system ipg, enpulse e2 ipg,enpulse e2 ipg,kap P980035/S404 10/19/2015 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 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
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
maximo ii dr,maximo ii vr,virtuoso ii vr,secura dr,secura vr P980016/S452 07/09/2014 Review Approval
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
surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin P990004/S019 05/17/2011 Review Approval
floseal hemostatic matrix 5 ml/10 ml kit P990009/S025 01/07/2010 Review Approval
dema ipg/c & t series ipgs P990001/S068 03/22/2011 Review Approval
dema ipg/c & t series ipgs P990001/S082 05/13/2011 Review Approval
vistatron c&t series (model vsf04 v8.0, model vsf 12 v8.0, model vsf08 v8.0) P990001/S105 03/13/2013 Review Approval
vitatron c20 sr ipg,vitatron c60 dr ipg,vitatron t20 sr ipg,vitatron t60 dr ipg P990001/S119 10/19/2015 Review Approval
evia/entovis pulse generators P000009/S035 05/07/2010 Review Approval
belos/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds P000009/S040 11/26/2010 Review Approval
implantable cv defibrillator/pacemaker programmer/icd monitoring system P000009/S042 04/15/2011 Review Approval
lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t icds P000009/S046 09/30/2011 Review Approval
belos dr/dr-t/vr/vr-t/lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t/xelos dr-t P000009/S047 05/04/2012 Review Approval
belos dr/dr-t/vr/vr-t, lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's P000009/S049 10/03/2012 Review Approval
belos & lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's P000009/S051 03/18/2013 Review Approval
xelos dr-t icd's P000009/S057 05/04/2014 Review Approval
lifevest wearable defibrillator P010030/S023 04/19/2011 Review Approval
lifevest waerable defibrillator P010030/S031 11/02/2012 Review Approval
consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization P010015/S084 03/22/2011 Review Approval
insync crt-p & insync iii crt-p P010015/S086 03/22/2011 Review Approval
insync crt-p/insync iii crt-p P010015/S107 05/13/2011 Review Approval
consulta crt-d/concerto ii crt-d/maximo crt-d icds P010031/S150 04/04/2011 Review Approval
consulta crt-p, syncra crt-p P010015/S157 06/04/2012 Review Approval
insync iii (model 9981 v8.0) P010015/S166 03/13/2013 Review Approval
protecta xt crt-d and protecta crt-d implantable cardioverter defibrillators with cardiac resynchronization; model sw009 P010031/S171 03/25/2011 Review Approval
medtronic consulta crt-d d204trm, maximo ii crt-d d264trm implantable cardioverter defibrillators P010031/S176 01/09/2012 Review Approval
medtronic protecta xt crt-d d314trm and protecta crt-d d334 implantable cardioverter defibrillators P010031/S178 11/09/2011 Review Approval
consulta crt-p, syncra crt-p P010015/S190 05/24/2013 Review Approval
concerto ii/consulta/maximo ii crt-ds P010031/S198 03/22/2011 Review Approval
consulta crt-p,syncra crt-p P010015/S208 09/27/2013 Review Approval
cognis 4-site models P010012/S212 11/10/2010 Review Approval
consulta crt-p, syncra crt-p P010015/S215 02/14/2014 Review Approval
viva crt-p,consulta crt-p,syncra crt-p P010015/S227 07/09/2014 Review Approval
concerto ii/maximo ii/consulta crt-ds P010031/S228 05/13/2011 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
incepta, energen, punctua and cognis crt-d P010012/S255 11/17/2011 Review Approval
consulta,syncra,viva crt-ps,insync ipg P010015/S255 10/19/2015 Review Approval
concert ii, consulta, & maximo ii crt-ds P010031/S296 06/04/2012 Review Approval
cognis, incepta, energen and punctua crt-d devices P010012/S300 11/30/2012 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
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
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
insync ii p rotect icd, insync iii marquis icd, insync marquis icd, insync maximo icd P010031/S363 05/24/2013 Review Approval
insync ii protect, insync iii marquis,insync marquis, insync maximo icds P010031/S386 09/27/2013 Review Approval
insync ii protect icd, iiimarquis icd, marquis icd, maximo icd, brava crt-d, concerto icd, ii crt-d, consulta icd, maxim P010031/S397 02/14/2014 Review Approval