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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
natrelle silicone filled breast implants P020056/S054 10/27/2021   Approval
memorygel/memorygel xtra breast implants P030053/S062 10/27/2021   Approval
natrelle saline filled breast implants P990074/S045 10/27/2021   Approval
saline-filled and spectrum breast implants P990075/S051 10/27/2021   Approval
memoryshape breast implants P060028/S041 10/27/2021   Approval
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