PMA P110033S033

Device: Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volbella XC
Applicant: Allergan
PMA number: P110033
Supplement: S033
Product code: LMH
Decision date: 2018-01-04
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for implementation of a scaled-up manufacturing process for the Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volbella XC dermal fillers

Current openFDA PMA Record#

Device: Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volbella XC
Applicant: Allergan
PMA number: P110033
Supplement: S033
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2018-01-04
Decision code: APPR
Date received: 2017-08-21
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for implementation of a scaled-up manufacturing process for the Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volbella XC dermal fillers