PMA P050047S066
- Device
- Juvederm Injectable Gel Implants
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S066
- Product code
- LMH
- Decision date
- 2019-03-13
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for the addition of a 0.55 mL-fill volume configuration in the same 1.0 mL COC syringe for Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC.
Current openFDA PMA Record#
- Device
- Juvederm Injectable Gel Implants
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S066
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-03-13
- Decision code
- APPR
- Date received
- 2018-12-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of a 0.55 mL-fill volume configuration in the same 1.0 mL COC syringe for Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC.