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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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Review
Memo		 Approval
Order
unify crt-d system P030054/S141 05/07/2010 Review Approval
transvene cs/svc lead P980050/S057 05/13/2011 Review Approval
transcyte human fibroblast-derived temporary skin substitute P960007/S021 09/20/2011 Review Approval
tendril sts lead model 1988tc P960013/S054 04/14/2010 Review Approval
tendril sts 1988tc and 2088tc P960013/S066 11/01/2011 Review Approval
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