PMA P050047S030

Device: JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC
Applicant: Allergan
PMA number: P050047
Supplement: S030
Product code: LMH
Decision date: 2013-03-11
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
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.

Current openFDA PMA Record#

Device: JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC
Applicant: Allergan
PMA number: P050047
Supplement: S030
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2013-03-11
Decision code: APPR
Date received: 2012-12-26
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.