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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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201 to 210 of 210 records
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Device
Name
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PMA
Number
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Decision
Date
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Review
Memo
Approval
Order
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
stratos lv/lv-t, evia and entovis hf/hf-t crt-p's P070008/S036 03/18/2013 Review Approval
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
revo mri ipg P090013/S085 05/24/2013 Review Approval
revo mri ipg P090013/S107 09/27/2013 Review Approval
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
 
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