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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 IMPLANTS
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP050047
Supplement NumberS020
Date Received09/26/2011
Decision Date01/20/2012
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN EXTENSION OF THE SHELF LIFE FROM 12 MONTHS TO 18 MONTHS FOR THE 1.0ML SYRINGE; AN INCREASE IN THE MONOETHYLGLYCIN-EXYLIDIDE (MEGX) IMPURITY SPECIFICATION FROM <=3% W/W OF LABEL STRENGTH TO <=2.5% W/W OF LABEL STRENGTH; AND AN INCREASE IN INDIVIDUAL UNIDENTIFIED IMPURITIES SPECIFICATIONS FROM <=0.1% W/W OF LABEL STRENGTH TO<=0.2% W/W OF LABEL STRENGTH.
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