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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
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S211 05/07/2012 Review Approval
microny family of pacemakers P970013/S044 05/07/2012 Review Approval
cadence/ellipse/fortify assura family of icds P910023/S279 05/07/2012 Review Approval
stratos lv/lv-t P070008/S028 05/04/2012 Review Approval
belos dr/dr-t/vr/vr-t/lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t/xelos dr-t P000009/S047 05/04/2012 Review Approval
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