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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
quickflex u model 1258t lead P030054/S130 05/10/2010 Review Approval
quadra assura/unify assura family pf crt-ds P030054/S254 02/26/2014 Review Approval
quadra assura/unify assura family of crt-ds P030054/S238 06/06/2013 Review Approval
quadra assura/unify assura family of crt-d's P030054/S273 09/12/2014 Review Approval
quadra assura / unify assura family of crt-d's P030054/S284 08/27/2015 Review  
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