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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namesaline-filled mammary prosthesis
Regulation Number878.3530
ApplicantMENTOR WORLDWIDE LLC
PMA NumberP990075
Date Received11/12/1999
Decision Date05/10/2000
Product Code
FWM[ Registered Establishments with FWM ]
Docket Number 01M-0011
Notice Date 01/18/2001
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the mentor corporation saline-filled and spectrum mammary prostheses.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S019 
S021 S022 S023 S024 S025 S026 
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