PMA P110033S023

Device
JUVEDERM VOLBELLA XC
Applicant
Allergan
PMA number
P110033
Supplement
S023
Product code
LMH
Decision date
2016-09-01
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for the addition of a 0.55 mL-filled syringe configuration in the same 1 mL COC syringe for Juvederm VOLBELLA XC.

Current openFDA PMA Record#

Device
JUVEDERM VOLBELLA XC
Applicant
Allergan
PMA number
P110033
Supplement
S023
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2016-09-01
Decision code
APPR
Date received
2016-06-14
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the addition of a 0.55 mL-filled syringe configuration in the same 1 mL COC syringe for Juvederm VOLBELLA XC.