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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 IMPLANT
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP990074
Supplement NumberS018
Date Received02/23/2007
Decision Date05/17/2007
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A TRADE NAME CHANGE FROM INAMED SALINE-FILLED BREAST IMPLANTS TO NATRELLE SALINE-FILLED BREAST IMPLANTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NATRELLE SALINE-FILLED BREAST IMPLANTS AND IS INDICATED FOR 1) BREAST AUGMENTATION FOR WOMEN 18 YEARS OR OLDER; AND 2) BREAST RECONSTRUCTION.
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