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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
Classification Nameprosthesis, breast, inflatable, internal, saline
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[ Registered Establishments with 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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