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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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Review
Memo		 Approval
Order
st jude medical, merlin psa ex3100 system P030054/S146 05/03/2010 Review Approval
unify crt-d system P030054/S141 05/07/2010 Review Approval
frontier / frontier ii / anthem family of crt-p's P030035/S133 08/27/2015 Review  
epic hf crt-d system P030054/S131 01/29/2010 Review Approval
quickflex u model 1258t lead P030054/S130 05/10/2010 Review Approval
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