PMA P110033S026

Device
Juvederm Voluma® XC and Juvederm Volbella® XC
Applicant
Allergan
PMA number
P110033
Supplement
S026
Product code
LMH
Decision date
2017-05-12
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for a change in the cleaning procedure for some equipment used in the manufacturing of injectable gel products

Current openFDA PMA Record#

Device
Juvederm Voluma® XC and Juvederm Volbella® XC
Applicant
Allergan
PMA number
P110033
Supplement
S026
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2017-05-12
Decision code
APPR
Date received
2017-02-09
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a change in the cleaning procedure for some equipment used in the manufacturing of injectable gel products