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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
Number
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Review
Memo		 Approval
Order
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S203 08/03/2011 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S229 06/06/2013 Review Approval
anthem, frontier ii crt-ps P030035/S082 12/04/2012 Review Approval
apligraf (graftskin) P950032/S016 06/20/2000   Approval
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds P030054/S188 12/04/2012 Review Approval
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