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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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Review
Memo		 Approval
Order
sensolog/ dialog/regency family of pacemakers P880006/S089 09/12/2014 Review Approval
sensolog / dialog/ regency family of pacemakers P880006/S093 08/27/2015 Review  
affinity/integrity/victory family of pacemakers P880086/S189 03/04/2011 Review Approval
affinity/integrity/victory family of pacemakers P880086/S195 04/04/2011 Review Approval
accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers P880086/S202 12/04/2012 Review Approval
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