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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 BREAST IMPLANTS
ApplicantMentor Worldwide, LLC
33 Technology Dr.
Irvin, CA 92618
PMA NumberP990075
Supplement NumberS006
Date Received07/26/2001
Decision Date08/09/2001
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LAL TESTING TO BE DONE ON A SKIP LOT AUDIT BASIS EVERY SIX MONTHS.
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