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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 ULTRA XC AND JUVEDERM ULTRA PLUS XC
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP050047
Supplement NumberS030
Date Received12/26/2012
Decision Date03/11/2013
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 18 MONTHS TO 20MONTHS FOR THE 1ML SYRINGE; AN INCREASE IN THE ONOETHYLGLYCINEXYLIDIDE (MEGX) IMPURITY SPECIFICATION FROM 2.5% TO 3.5% W/W OF THE LABEL STRENGTH AND TOTAL IMPURITIES FROM 3.0% TO 4.3% OF LABEL STRENGTH.
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