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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/S075 05/07/2012 Review Approval
sensolog/ dialog/regency family of pacemakers P880006/S081 04/10/2014 Review Approval
integrity afx dr model 5346 dual chamber pulse generator and programmer software model 3307, v2.2a P880086/S083 07/11/2001   Approval
sensolog/dialog/regency family of pacemakers P880006/S084 06/06/2013 Review Approval
sensolog/dialog/ regency family of pacemakers P880006/S087 02/26/2014 Review Approval
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