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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
33 technology drive
irvine, CA 92618
PMA NumberP990075
Supplement NumberS013
Date Received08/01/2003
Decision Date08/14/2003
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the quality control test specification to replace the tensile strength specification with a break force specification for the silicone elastomer fill tube component of the mentor spectrum saline-filled mammary prostheses.