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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
Name
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PMA
Number
Sort by PMA Number [0-9]
Sort by PMA Number [9-0]
Decision
Date
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Review
Memo		 Approval
Order
anthem, frontier ii crt-ps P030035/S082 12/04/2012 Review Approval
atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds P910023/S263 12/04/2012 Review Approval
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds P030054/S188 12/04/2012 Review Approval
teligen, incepta, energen and punctua icd devices P960040/S270 11/30/2012 Review Approval
cognis, incepta, energen and punctua crt-d devices P010012/S300 11/30/2012 Review Approval
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