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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
tendril sts 1988tc and 2088tc P960013/S066 11/01/2011 Review Approval
radiesse injectable implant P050052/S027 10/31/2011 Review Approval
radiesse injectable implant P050037/S024 10/31/2011 Review Approval
evia/entovis/estella/effecta/ecuro P950037/S098 09/30/2011 Review Approval
lumax 300/340 vr-t/dr-t/hf-t/lumax 500/540 vr-t/dr-t/hf-t/lumax 540 vr-t dx P050023/S046 09/30/2011 Review Approval
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