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PMA P110033S057

Device
Juvéderm Voluma XC, Juvéderm Vollure XC, and Juvéderm Volbella XC
Applicant
Allergan
PMA number
P110033
Supplement
S057
Product code
LMH
Decision date
2020-11-25
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for revisions to the clinician labeling of Juvéderm® Voluma XC, and patient labeling of Juvéderm® Voluma XC Cheek, Juvéderm® Voluma XC Chin, Juvéderm® Vollure XC, and Juvéderm® Volbella XC to include updated safety information based on post marketing surveillance data.

Current openFDA PMA Record#

Device
Juvéderm Voluma XC, Juvéderm Vollure XC, and Juvéderm Volbella XC
Applicant
Allergan
PMA number
P110033
Supplement
S057
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-11-25
Decision code
APPR
Date received
2020-10-30
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revisions to the clinician labeling of Juvéderm® Voluma XC, and patient labeling of Juvéderm® Voluma XC Cheek, Juvéderm® Voluma XC Chin, Juvéderm® Vollure XC, and Juvéderm® Volbella XC to include updated safety information based on post marketing surveillance data.