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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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Review
Memo
Approval
Order
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds P030054/S188 12/04/2012 Review Approval
epic hf/atlas+hf/promote/unify families of crt-ds P030054/S181 06/21/2011 Review Approval
epic hf/atlas+hf hamily of crt-ds P030054/S177 04/04/2011 Review Approval
cardiac resynchronization therapy defibrillator (crt-d) P030054/S173 11/29/2011 Review Approval
epic hr/atlas + hf family of crt-ds P030054/S153 03/04/2011 Review Approval
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