PMA P110033S091

Device: Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive
Applicant: Allergan
PMA number: P110033
Supplement: S091
Product code: LMH
Decision date: 2026-08-11
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for using the sodium hyaluronate manufactured from HTL’s additional manufacturing line (HTL4) as raw materials for Juvéderm products.

Current openFDA PMA Record#

Device: Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive
Applicant: Allergan
PMA number: P110033
Supplement: S091
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-08-11
Decision code: APPR
Date received: 2025-01-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for using the sodium hyaluronate manufactured from HTL’s additional manufacturing line (HTL4) as raw materials for Juvéderm products.