PMA P110033S102

Device: Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm
Applicant: Allergan
PMA number: P110033
Supplement: S102
Product code: LMH
Decision date: 2026-08-28
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for an automated Manufacturing Execution System used for the creation, execution, and management of the Electronic Batch Records (EBR) on Packaging Lines 3 and 4 in Pringy, France

Current openFDA PMA Record#

Device: Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm
Applicant: Allergan
PMA number: P110033
Supplement: S102
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-08-28
Decision code: OK30
Date received: 2026-07-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an automated Manufacturing Execution System used for the creation, execution, and management of the Electronic Batch Records (EBR) on Packaging Lines 3 and 4 in Pringy, France