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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 HYALURONATE GEL IMPKANTS
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP050047
Supplement NumberS019
Date Received08/01/2011
Decision Date09/23/2011
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR AN EXTENSION OF THE SHELF LIFE FROM 12 MONTHS TO 24 MONTHS FOR THE 0.8ML SYRINGE (0.4ML AND 0.8ML VOLUMES); AN INCREASE IN THE MONOETHYLGLYCINEXYIDIDE (MEGX) IMPURITY SPECIFICATION FROM <= 0.3% W/W OF LABEL STRENGTH TO <= 2.0% W/W OF LABEL STRENGTH; AND AN INCREASE IN TOTAL IMPURITIES SPECIFICATION FROM <= 0.5% W/W OF LABEL STRENGTH TO <= 2.5% W/W OF LABEL STRENGTH.
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