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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
carelink monitor, cardiosight reader, carelink express monitor P890003/S338 02/01/2016 Review  
restylane/restylane-l/ perlane/ perlane-l , restylane silk(injectable gels) P040024/S079 01/26/2016 Review  
iforia 7 dr-t (df-1 & df4), iperia 7 dr-t (df-1 & df-4), inventra 7 dr-t (df-1 & df-4) P050023/S087 12/21/2015 Review  
linox smart(s65)(sd65/18)(sdx65/15&65/17),protego df-1(s65)(sd65/18)(dx65/15&65/17),protego(s65&75)(sd65/16,65/18,75/18) P950037/S151 12/21/2015 Review  
programmer software(1503.u) for ics 3000/renamic programmers P000009/S063 12/21/2015 Review  
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