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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
ellipse / fortify assura family of icd's P910023/S342 09/12/2014 Review Approval
ellipse/fortify assura family of icd's P910023/S355 08/27/2015 Review  
medtronic sprint quattro secure lead model 6947m P920015/S055 01/09/2012 Review Approval
model 5019 high voltage (hv) splitter/adaptor kit P920015/S093 02/13/2013 Review Approval
medtronic pcd tachyarrhythmia control system P920015/S146 10/19/2015 Review Approval
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