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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 Dr.
Irvin, 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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN INCREASED SHELL THICKNESS OF THE CONTOUR TALL PROFILE STYLES 5000, 5000PT, 6000, AND 6000PT.
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