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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
frontier/frontier ii/ anthem family of crt-ps P030035/S115 02/26/2014 Review Approval
microny family of pacemakers P970013/S057 02/26/2014 Review Approval
affinity/ integrity/ victory/ zephyr/accent family of pacemakers P880086/S237 02/26/2014 Review Approval
capsure sense lead P830061/S086 02/18/2014 Review Approval
mycarelink patient monitor, device data management application, application software P890003/S285 02/14/2014 Review Approval
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