PMA P050047S058
- Device
- Juvéderm Ultra, Ultra XC, Ultra, Juvéderm Ultra XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S058
- Product code
- LMH
- Decision date
- 2017-08-25
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for an additional syringe assembly and packaging line.
Current openFDA PMA Record#
- Device
- Juvéderm Ultra, Ultra XC, Ultra, Juvéderm Ultra XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S058
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2017-08-25
- Decision code
- APPR
- Date received
- 2017-03-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional syringe assembly and packaging line.