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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.
 
DeviceMCGHAN SALINE-FILLED BREAST IMPLANTS
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP990074
Supplement NumberS005
Date Received01/29/2001
Decision Date04/09/2001
Product Code FWM 
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 NEW SERIES OF SIZES FOR THE STYLE 363 SALINE-FILLED BREAST IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MCGHAN SALINE-FILLED BREAST IMPLANTS, STYLE 363LF AND IS INDICATED FOR: 1) BREAST AUGMENTATION FOR WOMEN 18 YEARS OR OLDER AND 2) BREAST RECONSTRUCTION.
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