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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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Review
Memo		 Approval
Order
5076 capsurefix novus surescan leads P930039/S138 09/11/2015 Review  
5086 mri capsurefix mri surescan leads P090013/S200 09/11/2015 Review  
accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers P880086/S202 12/04/2012 Review Approval
ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar P900061/S098 05/13/2011 Review Approval
activitrax ii ipg,activitrax ipg,legend ii ipg,legend ipg,micro minix ipg,minix ipg,minix st ipg,premier ipg,prevail ipg P850051/S082 10/19/2015 Review Approval
adapta versa, sensia ipg, advisa dr ipg, advisa dr mri ipg and enpulse e1 ipg P980035/S311 05/24/2013 Review Approval
adapta, versa, sensia ipg, advisa dr ipg, dr mri ipg, enpulse el ipg, e2 ipg, enrhythm ipg, kappa d ipg P980035/S343 02/14/2014 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
adapta,versa,sensia,advisa dr,advisa dr mri,enpulse e1,enpulse e2,enrhythm,kappa d(kappa 700),kappa d (kappa 900) ipg, k P980035/S338 09/27/2013 Review Approval
advisa dr ipg P980035/S264 06/04/2012 Review Approval
advisa dr ipg P980035/S134 04/04/2011 Review Approval
advisa dr,advisa dr mri P980035/S358 07/09/2014 Review Approval
advisa sr ipg P980035/S424 06/22/2015 Review  
affinity, integrity, victory, zephyr, & accent family of pacemakers P880086/S245 09/12/2014 Review Approval
affinity/ integrity/ victory/ zephyr/accent family of pacemakers P880086/S237 02/26/2014 Review Approval
affinity/integrity / victory /zephyr accent family of pacemakers P880086/S255 08/27/2015 Review  
affinity/integrity/victory family of pacemakers P880086/S189 03/04/2011 Review Approval
affinity/integrity/victory family of pacemakers P880086/S195 04/04/2011 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S203 08/03/2011 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S211 05/07/2012 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S220 04/10/2014 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S229 06/06/2013 Review Approval
anthem, frontier ii crt-ps P030035/S082 12/04/2012 Review Approval
apligraf (graftskin) P950032/S016 06/20/2000   Approval
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds P030054/S188 12/04/2012 Review Approval
atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds P910023/S263 12/04/2012 Review Approval
attain ability model 4x96 lead P080006/S063 05/15/2014 Review Approval
attain ability mri , plus mri,straight mri surescan; attain performa mri, straight ans s mri surescan P080006/S085 02/01/2016 Review  
attain performa model 4398 and 4598 left ventricular leads P080006/S073 12/10/2014 Review  
attain starfix lead P060039/S059 09/04/2014 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
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 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/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds P000009/S040 11/26/2010 Review Approval
brava crt-d, brava quad crt-d, viva quad s crt-d, viva quad xt crt-d, viva s crt-d, viva xt crt-d P010031/S511 10/29/2015 Review  
brava crt-d,viva s crt-d,viva xt crt-d,viva/brava/evera programmer application software P010031/S413 02/27/2014 Review Approval
brava,brava quad,concerto ii,consulta,maximo ii,protecta,protecta xt,viva quad s, viva quad xt,viva s, viva xt crt-ds, c P010031/S478 10/19/2015 Review Approval
cadence family of icds P910023/S236 03/04/2011 Review Approval
cadence family of icds P910023/S215 01/29/2010 Review Approval
cadence family of icds P910023/S264 08/03/2011 Review Approval
cadence family of icds P910023/S270 03/09/2012 Review Approval
cadence family of icds P910023/S254 04/04/2011 Review Approval
cadence/current/fortify families of icds P910023/S257 06/21/2011 Review Approval
cadence/ellipse/fortify assura family of icd's P910023/S297 04/10/2014 Review Approval
cadence/ellipse/fortify assura family of icds P910023/S279 05/07/2012 Review Approval
cameron health subcutaneous implantable defibrillator s-icd system P110042/S002 03/07/2013 Review Approval
capsure sense lead P830061/S086 02/18/2014 Review Approval
capsurefix mri surescan P090013/S202 02/01/2016 Review  
capsurefix novus mri surescan P930039/S140 02/01/2016 Review  
capsurefix novus mri surescan lead model 5076 P930039/S130 06/22/2015 Review  
 
 
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