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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceMENTOR SALINE-FILLED BREAST IMPLANTS
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
Applicant
MENTOR WORLDWIDE LLC
201 mentor drive
santa barbara, CA 93111
PMA NumberP990075
Supplement NumberS023
Date Received05/01/2013
Decision Date05/15/2013
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 
Add an additional supplier of the diaphragm valve component used in the manufacture of the mentor saline-filled breast implants.
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