- Device
- Juvéderm Ultra, Ultra XC, Ultra Plus, and Ultra Plus XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S077
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-07-17
- Decision code
- APPR
- Date received
- 2020-06-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revisions to the clinician labeling of Juvéderm® Ultra, Juvéderm® Ultra XC, Juvéderm® Ultra Plus, Juvéderm® Ultra Plus XC, Juvéderm® Vollure XC, and Juvéderm® Volbella XC to include updated safety information based on post marketing surveillance data