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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMENTOR MEMORYSHAPE BREAST IMPLANTS
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantMENTOR WORLDWIDE LLC
33 Technology Drive
Irvine, CA 92618
PMA NumberP060028
Supplement NumberS018
Date Received06/07/2016
Decision Date07/05/2016
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Use of previously approved Semi-Automated Primary Packaging Equipment SPPS following relocation from the Main Assembly Controlled Manufacturing Environment CME room to the Primary Packaging CME Room at the Mentor Irving, Texas facility.
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