FDA.reportPublic FDA data

PMA P110033S055

Device
Juvéderm Vollure XC and Volbella XC
Applicant
Allergan
PMA number
P110033
Supplement
S055
Product code
LMH
Decision date
2020-07-17
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for revisions to the clinician labeling of Juvéderm® Ultra, Juvéderm® Ultra XC, Juvéderm® Ultra Plus, Juvéderm® Ultra Plus XC, Juvéderm® Vollure XC, and Juvéderm® Volbella XC to include updated safety information based on post marketing surveillance data.

Current openFDA PMA Record#

Device
Juvéderm Vollure XC and Volbella XC
Applicant
Allergan
PMA number
P110033
Supplement
S055
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-07-17
Decision code
APPR
Date received
2020-06-19
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® Ultra, Juvéderm® Ultra XC, Juvéderm® Ultra Plus, Juvéderm® Ultra Plus XC, Juvéderm® Vollure XC, and Juvéderm® Volbella XC to include updated safety information based on post marketing surveillance data.