PMA P050047S080
- Device
- Juvederm Gel Implants
- Applicant
- Allergan
- Product code
- LMH
- Decision date
- 2021-07-21
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval of the implementation of additional cleanrooms for the manufacturing of Juvéderm® Gel Implants and Juvéderm® Injectable Gel.
Current openFDA PMA Record#
- Device
- Juvederm Gel Implants
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S080
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-07-21
- Decision code
- APPR
- Date received
- 2021-01-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of the implementation of additional cleanrooms for the manufacturing of Juvéderm® Gel Implants and Juvéderm® Injectable Gel.