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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
subcutaneous implantable defibrillator (s-icd) system P110042/S029 08/22/2014 Review Approval
subcutaneous implantable defibrillator (s-icd) system P110042/S009 08/28/2013 Review Approval
cameron health subcutaneous implantable defibrillator s-icd system P110042/S002 03/07/2013 Review Approval
cardiomems hf pressure measurement system P100045/S002 07/10/2015 Review  
capsurefix mri surescan P090013/S202 02/01/2016 Review  
5086 mri capsurefix mri surescan leads P090013/S200 09/11/2015 Review  
revo mri ipg P090013/S165 10/19/2015 Review Approval
revo mri ipg P090013/S112 02/14/2014 Review Approval
revo mri ipg P090013/S107 09/27/2013 Review Approval
revo mri ipg P090013/S085 05/24/2013 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 ability model 4x96 lead P080006/S063 05/15/2014 Review Approval
medtronic attain ability straight model 4396 left ventricular lead P080006/S004 03/31/2011 Review Approval
medtronic attain ability plus model 4296 lead P080006/S002 04/01/2011 Review Approval
programmer software (1503.u) for the ics 3000/renamic programmers P070008/S063 12/21/2015 Review  
celerity 2d/3d/pilot steroid-eluting lv lead, corox (-s/-l) bp steroid-eluting lv lead P070008/S054 09/16/2014 Review Approval
evia crt-p's P070008/S050 05/04/2014 Review Approval
stratos lv/lv-t, evia and entovis hf/hf-t crt-p's P070008/S036 03/18/2013 Review Approval
sientra opus silicone gel breast implants P070004/S033 10/27/2021   Approval
stratos lv/lv-t P070008/S031 10/03/2012 Review Approval
stratos lv/lv-t P070008/S028 05/04/2012 Review Approval
corox otw-l bp leads P070008/S026 09/30/2011 Review Approval
stratos lv/lv-t P070008/S019 04/15/2011 Review Approval
stratos lv/lv-t crt-p P070008/S017 11/26/2010 Review Approval
corox otw-l bp left ventricular pacing lead P070008/S015 12/23/2010 Review Approval
evia/entovis pulse generators P070008/S011 05/07/2010 Review Approval
intensia crt-d P060027/S066 11/04/2014   Approval
attain starfix lead P060039/S059 09/04/2014 Review Approval
paradym rf:models vr 9250, dr 9550, crt-d 9750; paradym models vr 8250, dr 8550, crt-d 8750 P060027/S053 03/06/2014 Review Approval
memoryshape breast implants P060028/S041 10/27/2021   Approval
paradym rf crt-d P060027/S038 05/09/2013   Approval
paradym crt P060027/S032 04/10/2012   Approval
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 P060027/S026 09/09/2010 Review Approval
model 4195 attain starfix lead P060039/S021 11/22/2011 Review Approval
paradym crt-d model 8750 P060027/S015 04/07/2010 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/iforia 5/7 vrt/drt icd's, ilesto/iforia 5/7 hf-t crt-d P050023/S076 07/03/2014 Review Approval
ilesto icd's and crt-d's P050023/S074 05/04/2014 Review Approval
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
kronos lv-t crt-d and lumax 300/340 & 500/540 crt-d's & icd's P050023/S053 10/03/2012 Review Approval
lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t P050023/S048 05/04/2012 Review Approval
lumax 500/540 icds thoracic impedance P050023/S047 11/17/2011 Review Approval
lumax 300/340 vr-t/dr-t/hf-t/lumax 500/540 vr-t/dr-t/hf-t/lumax 540 vr-t dx P050023/S046 09/30/2011 Review Approval
lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t P050023/S039 04/15/2011 Review Approval
various models of lumax icd/crt-d families P050023/S033 11/26/2010 Review Approval
radiesse injectable implant P050052/S027 10/31/2011 Review Approval
kronos lv-t and lumax 300/340 & 500/540 hf/hf-t P050023/S024 05/07/2010 Review Approval
radiesse injectable implant P050037/S024 10/31/2011 Review Approval
vitagel surgical hemostat P050044/S021 10/11/2013 Review  
 
 
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