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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 Dr.
Irvin, CA 92618
PMA NumberP030053
Supplement NumberS032
Date Received10/21/2015
Decision Date11/20/2015
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGES IN THE MANUFACTURING PROCESS OF THE PRIMARY PACKAGING EQUIPMENT, AND DEFECT CLASSIFICATION OF THE PRIMARY PACKAGING VISUAL INSPECTION PROCEDURE.
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