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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
Sort by PMA Number [0-9]
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Decision
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Review
Memo		 Approval
Order
ellipse/fortify assura family of icd's P910023/S355 08/27/2015 Review  
quadra assura / unify assura family of crt-d's P030054/S284 08/27/2015 Review  
frontier / frontier ii / anthem family of crt-p's P030035/S133 08/27/2015 Review  
microny family of pacemakers P970013/S064 08/27/2015 Review  
affinity/integrity / victory /zephyr accent family of pacemakers P880086/S255 08/27/2015 Review  
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