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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.
 
DeviceMEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS
Generic Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
Applicant
MENTOR CORP.
33 technology drive
irvine, CA 92618
PMA NumberP030053
Supplement NumberS030
Date Received08/26/2015
Decision Date09/24/2015
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 Product No
Approval Order Statement 
CHANGE THE SAMPLE SIZE FOR IN-PROCESS SILICONE GEL PENETRATION TESTING CONDUCTED AT THE MENTOR IRVING, TEXAS MANUFACTURING FACILITY.
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