|
Device | JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P050047 |
Supplement Number | S030 |
Date Received | 12/26/2012 |
Decision Date | 03/11/2013 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |