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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
dynagen & dynagen x4 crt-d's; inogen & inogen x4 crt-d's; origen & origen x4 crt-d's; cognis crt-d P010012/S341 04/11/2014 Review Approval
epic hf/atlas + hf/quandra assura/unify assura family of crt-d's P030054/S226 04/10/2014 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S220 04/10/2014 Review Approval
cadence/ellipse/fortify assura family of icd's P910023/S297 04/10/2014 Review Approval
frontier/ frontier ii /anthem family of crt-p's P030035/S098 04/10/2014 Review Approval
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