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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 NumberS013
Date Received01/25/2013
Decision Date02/24/2014
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF SEVEN STYLES INCLUDING FOUR SMOOTH ROUND ULTRA HIGH PROFILE DEVICES: 350-5650BC, 350-57000BC, 350-5750BC, AND 350-5800BC; AND THREE SILTEX ROUND ULTRA HIGH PROFILE DEVICES: 354-5590, 354-5650, AND 354-5700.
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