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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/SPECTRUM MAMMARY PROSTHESES
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantMENTOR WORLDWIDE LLC
33 Technology Drive
Irvine, CA 92618
PMA NumberP990075
Supplement NumberS008
Date Received05/10/2002
Decision Date06/07/2002
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE OF SUPPLIER FOR MOLDED SILICONE COMPONENTS TO PORGES, DIVISION OF MENTOR, SARLAT SEDEX, FRANCE AND A CHANGE IN SUPPLIER OF THE RAW MATERIAL FROM DOW CORNING TO NUSIL FOR ONE MOLDED COMPONENT.
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