PMA P050047S054
- Device
- Juvederm Ultra, Ultra XC, Ultra Plus, Ultra Plus XC, 30; Juvedern Ultra XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S054
- Product code
- LMH
- Decision date
- 2016-12-16
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Implementation of additional manufacturing capabilities within the existing syringe assembly and packaging line.
Current openFDA PMA Record#
- Device
- Juvederm Ultra, Ultra XC, Ultra Plus, Ultra Plus XC, 30; Juvedern Ultra XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S054
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2016-12-16
- Decision code
- OK30
- Date received
- 2016-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of additional manufacturing capabilities within the existing syringe assembly and packaging line.