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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
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Review
Memo		 Approval
Order
restylane/restylane-l/ perlane/ perlane-l , restylane silk(injectable gels) P040024/S079 01/26/2016 Review  
restylane l and perlane l injectable gels P040024/S039 01/29/2010 Review Approval
restylane injectable gel P040024/S052 07/18/2011 Review Approval
reply/esprit sr and dr model pacemakers P950029/S079 06/20/2013 Review Approval
reocor s / d family of external pacemakers P950037/S084 05/08/2012 Review Approval
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