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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
ApplicantMENTOR CORP.
33 TECHNOLOGY DRIVE
IRVINE, CA 92618
PMA NumberP030053
Supplement NumberS018
Date Received07/02/2014
Decision Date07/30/2014
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  
CHANGE TO REMOVE THE IN PROCESS GEL COHESION TEST THAT IS PERFORMED DURING THE MANUFACTURE OF THE GEL THAT IS USED TO FILL THE MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS AT MENTOR'S IRVING, TEXAS FACILITY.
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