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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 MAMMARY PROSTHESES
ApplicantMENTOR WORLDWIDE LLC
33 Technology Drive
Irvine, CA 92618
PMA NumberP990075
Supplement NumberS002
Date Received10/23/2000
Decision Date12/22/2000
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN INCREASED SHELL THICKNESS OF THE CONTOUR TALL PROFILE STYLES 5000, 5000PT, 6000, AND 6000PT.
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