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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 MAMMARY PROSTHESES
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 NumberS005
Date Received07/09/2001
Decision Date10/31/2001
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised patient labeling that incorporates the results of the focus group study.
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