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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.
 
DeviceNATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP040046
Supplement NumberS006
Date Received01/17/2014
Decision Date02/14/2014
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE STERILIZATION VALIDATION METHOD, INCLUDING A CHANGE IN THE D-VALUE OF THE BIOLOGICAL INDICATORS AND A CHANGE IN THE VALIDATION PROTOCOL METHOD.
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