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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceINAMED SILICONE-FILLED BREAST IMPLANTS
Generic NameProsthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP020056
Supplement NumberS001
Date Received01/31/2007
Decision Date08/22/2007
Product Code FTR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE IN LA AURORA DE HEREDIA, COSTA RICA.
Post-Approval StudyShow Report Schedule and Study Progress
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