PMA P110033S031

Device
Juvederm Volbella XC
Applicant
Allergan
PMA number
P110033
Supplement
S031
Product code
LMH
Decision date
2017-10-27
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for a change to the needle packaged with Juvederm Volbella XC, from 30G 1/2 inch to 32G 1/2 inch needles.

Current openFDA PMA Record#

Device
Juvederm Volbella XC
Applicant
Allergan
PMA number
P110033
Supplement
S031
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2017-10-27
Decision code
APPR
Date received
2017-08-04
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to the needle packaged with Juvederm Volbella XC, from 30G 1/2 inch to 32G 1/2 inch needles.