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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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Review
Memo		 Approval
Order
memoryshape breast implants P060028/S041 10/27/2021   Approval
paradym rf crt-d P060027/S038 05/09/2013   Approval
paradym crt P060027/S032 04/10/2012   Approval
paradym implant software version w2.8.4, and associated programmer software smartview 2.22ug1 P060027/S026 09/09/2010 Review Approval
model 4195 attain starfix lead P060039/S021 11/22/2011 Review Approval
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