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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.
 
DeviceJUVEDERM HYALURONANTE GEL IMPLANTS
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP050047
Supplement NumberS002
Date Received11/13/2007
Decision Date11/30/2007
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CLARIFICATIONS TO THE NEEDLE ATTACHMENT INSTRUCTIONS AND JUVEDERM 30 PHYSICIAN INSTRUCTIONS.
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