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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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PMA
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Decision
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Review
Memo		 Approval
Order
stratos lv/lv-t crt-p P070008/S017 11/26/2010 Review Approval
stratos lv/lv-t P070008/S019 04/15/2011 Review Approval
corox otw-l bp leads P070008/S026 09/30/2011 Review Approval
stratos lv/lv-t P070008/S028 05/04/2012 Review Approval
stratos lv/lv-t P070008/S031 10/03/2012 Review Approval
sientra opus silicone gel breast implants P070004/S033 10/27/2021   Approval
stratos lv/lv-t, evia and entovis hf/hf-t crt-p's P070008/S036 03/18/2013 Review Approval
evia crt-p's P070008/S050 05/04/2014 Review Approval
celerity 2d/3d/pilot steroid-eluting lv lead, corox (-s/-l) bp steroid-eluting lv lead P070008/S054 09/16/2014 Review Approval
programmer software (1503.u) for the ics 3000/renamic programmers P070008/S063 12/21/2015 Review  
medtronic attain ability plus model 4296 lead P080006/S002 04/01/2011 Review Approval
medtronic attain ability straight model 4396 left ventricular lead P080006/S004 03/31/2011 Review Approval
attain ability model 4x96 lead P080006/S063 05/15/2014 Review Approval
attain performa model 4398 and 4598 left ventricular leads P080006/S073 12/10/2014 Review  
attain ability mri , plus mri,straight mri surescan; attain performa mri, straight ans s mri surescan P080006/S085 02/01/2016 Review  
revo mri ipg P090013/S085 05/24/2013 Review Approval
revo mri ipg P090013/S107 09/27/2013 Review Approval
revo mri ipg P090013/S112 02/14/2014 Review Approval
revo mri ipg P090013/S165 10/19/2015 Review Approval
5086 mri capsurefix mri surescan leads P090013/S200 09/11/2015 Review  
capsurefix mri surescan P090013/S202 02/01/2016 Review  
cardiomems hf pressure measurement system P100045/S002 07/10/2015 Review  
cameron health subcutaneous implantable defibrillator s-icd system P110042/S002 03/07/2013 Review Approval
subcutaneous implantable defibrillator (s-icd) system P110042/S009 08/28/2013 Review Approval
subcutaneous implantable defibrillator (s-icd) system P110042/S029 08/22/2014 Review Approval
 
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