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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
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Review
Memo		 Approval
Order
microny family of pacemakers P970013/S044 05/07/2012 Review Approval
epic hf/atlas+hf/quadra assura/unify assura family of crt-ds P030054/S206 05/07/2012 Review Approval
cadence/ellipse/fortify assura family of icds P910023/S279 05/07/2012 Review Approval
lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t P050023/S048 05/04/2012 Review Approval
cylos/dr/dr-t/vr/dromos dr/sr/sl/kairos dr/sr/sl/d/s/philos/dr/dr-t/sr/slr/d/s/philos ii d/dr/s/slr/sr/dr-t/protos dr/cl P950037/S100 05/04/2012 Review Approval
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