PMA P110033S030

Device: Juvéderm Voluma XC, Juvéderm VollureTM XC, Juvéderm Volbella XC
Applicant: Allergan
PMA number: P110033
Supplement: S030
Product code: LMH
Decision date: 2017-05-25
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Implementation of two additional equipment to support automated visual inspection of 1 mL syringes filled to 1.0 mL product configurations.

Current openFDA PMA Record#

Device: Juvéderm Voluma XC, Juvéderm VollureTM XC, Juvéderm Volbella XC
Applicant: Allergan
PMA number: P110033
Supplement: S030
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2017-05-25
Decision code: OK30
Date received: 2017-05-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of two additional equipment to support automated visual inspection of 1 mL syringes filled to 1.0 mL product configurations.