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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 MEMORYGEL GEL-FILLED BREAST IMPLANTS
Generic Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantMENTOR CORP.
33 technology drive
irvine, CA 92618
PMA NumberP030053
Supplement NumberS002
Date Received12/20/2006
Decision Date02/08/2008
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO A LOW BLEED PATCH DESIGN FOR THE DEVICE.
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