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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 NumberS008
Date Received05/10/2002
Decision Date06/07/2002
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 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.