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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 SALINE-FILLED AND SPECTRUM BREAST IMPLANT
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
Applicant
MENTOR WORLDWIDE LLC
33 technology drive
irvine, CA 92618
PMA NumberP990075
Supplement NumberS033
Date Received06/10/2015
Decision Date07/01/2015
Product Code FWM 
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 
CHANGES TO ADD A NEW CLEAN MANUFACTURING ENVIRONMENT (CME) ROOM FOR THE STORAGE OF DEVICE COMPONENT SHELLS. THE BREAST IMPLANTS ARE MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
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