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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
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S203 08/03/2011 Review Approval
microny family of pacemakers P970013/S040 08/03/2011 Review Approval
cadence family of icds P910023/S264 08/03/2011 Review Approval
sensolog/dialog/regency family of pacemakers P880006/S071 08/03/2011 Review Approval
epic hf/atlas + hf family of crt-ds P030054/S189 08/03/2011 Review Approval
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