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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
epic hf/atlas + hf/quandra assura/unify assura family of crt-d's P030054/S226 04/10/2014 Review Approval
unify quadra crt-d, unify quadra assura P030054/S223 08/09/2012 Review Approval
epic hf/atlas+hf/quadra assura/unify assura family of crt-ds P030054/S206 05/07/2012 Review Approval
epic hf/atlas + hf family P030054/S196 03/09/2012 Review Approval
epic hf/atlas + hf family of crt-ds P030054/S189 08/03/2011 Review Approval
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