PMA P050047S068
- Device
- Juvederm Ultra XC and Ultra Plus XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S068
- Product code
- LMH
- Decision date
- 2019-04-04
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for the addition of a specification for the lidocaine-related impurity, 2,6-dimethylaniline (DMA).
Current openFDA PMA Record#
- Device
- Juvederm Ultra XC and Ultra Plus XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S068
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-04-04
- Decision code
- APPR
- Date received
- 2019-03-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of a specification for the lidocaine-related impurity, 2,6-dimethylaniline (DMA).