PMA P050047S064
- Device
- Juvederm Ultra, Ultra XC, Ultra Plus, and Juvederm Ultra Plus XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S064
- Product code
- LMH
- Decision date
- 2018-05-01
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- New ISO Class 8 cleanroom for use during the manufacturing of Juvéderm injectable gel products.
Current openFDA PMA Record#
- Device
- Juvederm Ultra, Ultra XC, Ultra Plus, and Juvederm Ultra Plus XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S064
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2018-05-01
- Decision code
- OK30
- Date received
- 2018-04-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New ISO Class 8 cleanroom for use during the manufacturing of Juvéderm injectable gel products.