PMA P050047S086
- Device
- Juvéderm Ultra, Ultra XC, Juvéderm Ultra XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S086
- Product code
- LMH
- Decision date
- 2022-08-05
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Implementing an additional duplicate syringe assembly and packaging line for manufacturing Juvéderm injectable gel products.
Current openFDA PMA Record#
- Device
- Juvéderm Ultra, Ultra XC, Juvéderm Ultra XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S086
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-08-05
- Decision code
- OK30
- Date received
- 2022-07-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementing an additional duplicate syringe assembly and packaging line for manufacturing Juvéderm injectable gel products.