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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 IMPLANTS
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 NumberS032
Date Received04/02/2015
Decision Date04/29/2015
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 
CHANGE TO CONVERT AN EXISTING IN-PROCESS COMPONENT STORAGE AREA INTO A CLEAN MANUFACTURING ENVIRONMENT (CME) FOR THE MANUFACTURE OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED, MEMORYSHAPE, AND SALINE-FILLED AND SPECTRUM BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
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