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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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PMA
Number
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Decision
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Review
Memo
Approval
Order
stratos lv/lv-t crt-p P070008/S017 11/26/2010 Review Approval
medtronics adapta, versa, sensia and relia implantable pulse generator P980035/S150 12/08/2010 Review Approval
corox otw-l bp left ventricular pacing lead P070008/S015 12/23/2010 Review Approval
durata family of leads P950022/S069 01/24/2011 Review Approval
epic hr/atlas + hf family of crt-ds P030054/S153 03/04/2011 Review Approval
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