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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
advisa dr ipg P980035/S264 06/04/2012 Review Approval
reocor s / d family of external pacemakers P950037/S084 05/08/2012 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S075 05/07/2012 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S089 05/07/2012 Review Approval
epic hf/atlas+hf/quadra assura/unify assura family of crt-ds P030054/S206 05/07/2012 Review Approval
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