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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
various models of lumax icd/crt-d families P050023/S033 11/26/2010 Review Approval
radiesse injectable implant P050052/S027 10/31/2011 Review Approval
kronos lv-t and lumax 300/340 & 500/540 hf/hf-t P050023/S024 05/07/2010 Review Approval
radiesse injectable implant P050037/S024 10/31/2011 Review Approval
vitagel surgical hemostat P050044/S021 10/11/2013 Review  
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