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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 NumberS022
Date Received10/13/2009
Decision Date11/10/2009
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 EXPIRATION DATE OF A RAW MATERIAL.
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