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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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PMA
Number
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Decision
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Review
Memo		 Approval
Order
ellipse / fortify assura family of icd's P910023/S342 09/12/2014 Review Approval
frontier/ frontier ii / anthem family of crt-p's P030035/S123 09/12/2014 Review Approval
quadra assura/unify assura family of crt-d's P030054/S273 09/12/2014 Review Approval
affinity, integrity, victory, zephyr, & accent family of pacemakers P880086/S245 09/12/2014 Review Approval
microny family of pacemakers P970013/S060 09/12/2014 Review Approval
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