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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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Decision
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Review
Memo		 Approval
Order
epic hr/atlas + hf family of crt-ds P030054/S153 03/04/2011 Review Approval
senslog/dialog/regency family of pacemakers P880006/S067 03/04/2011 Review Approval
frontier/frontier 2 family of crt-ps P030035/S070 03/04/2011 Review Approval
microny family of pacemakers P970013/S034 03/04/2011 Review Approval
affinity/integrity/victory family of pacemakers P880086/S189 03/04/2011 Review Approval
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