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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
Name
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Review
Memo
Approval
Order
epic hf/atlas+hf hamily of crt-ds P030054/S177 04/04/2011 Review Approval
frontier/frontier ii family of crt-ps P030035/S075 04/04/2011 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S070 04/04/2011 Review Approval
affinity/integrity/victory family of pacemakers P880086/S195 04/04/2011 Review Approval
cadence family of icds P910023/S254 04/04/2011 Review Approval
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