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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 NumberS010
Date Received04/02/2015
Decision Date04/29/2015
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO CONVERT AN EXISTING IN-PROCESS COMPONENT STORAGE AREA INTO A CLEAN MANUFACTURING ENVIRONMENT (CME) FOR THE MANUFACTURE OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED, MEMORYSHAPE, AND SALINE-FILLED AND SPECTRUM BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
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