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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 NumberS015
Date Received06/05/2003
Decision Date07/22/2003
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT INAMED CORPORATION, WICKLOW, IRELAND.
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