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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 SPECTRUM SALINE-FILLED MAMARY PROSTHESES
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantMentor Worldwide, LLC
33 Technology Dr.
Irvin, CA 92618
PMA NumberP990075
Supplement NumberS007
Date Received03/26/2002
Decision Date04/23/2002
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE OF A SUPPLIER OF SILICONE GEL MATERIALS USED IN THE LUBRICATION OF THE SPECTRUM VALVE CHANNEL IN THE MENTOR SPECTRUM SALINE-FILLED BREAST IMPLANTS. THERE WILL BE NO CHANGES IN ANY MANUFACTURING PROCESSES.
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