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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
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Review
Memo		 Approval
Order
tendril sts lead model 1988tc P960013/S054 04/14/2010 Review Approval
st jude medical, merlin psa ex3100 system P030054/S146 05/03/2010 Review Approval
evia / entovis & various other pulse generators P950037/S072 05/07/2010 Review Approval
unify crt-d system P030054/S141 05/07/2010 Review Approval
fortify dr / vr icd systems P910023/S226 05/07/2010 Review Approval
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