- Device
- Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus, and Juvéderm Ultra Plus XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S079
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-11-25
- Decision code
- APPR
- Date received
- 2020-10-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revisions to the patient labeling of Juvéderm® Ultra, Juvéderm® Ultra Plus, Juvéderm® Ultra XC Wrinkles and Folds, Juvéderm® Ultra XC Lips, and Juvéderm® Ultra Plus XC to include updated safety information based on post marketing surveillance data.