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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 SALINE-FILLED BREAST IMPLANTS
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantAllergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP990074
Supplement NumberS032
Date Received09/29/2014
Decision Date10/29/2014
Product Code FWM 
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 BIOBURDEN TESTING METHOD AND SAMPLES USED FOR TESTING.
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