PMA P050047S098
- Device
- Ultra, Ultra XC, Ultra Plus XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S098
- Product code
- LMH
- Decision date
- 2026-08-11
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for using the sodium hyaluronate manufactured from HTL’s additional manufacturing line (HTL4) as raw materials for Juvéderm products.
Current openFDA PMA Record#
- Device
- Ultra, Ultra XC, Ultra Plus XC
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S098
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-08-11
- Decision code
- APPR
- Date received
- 2025-01-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for using the sodium hyaluronate manufactured from HTL’s additional manufacturing line (HTL4) as raw materials for Juvéderm products.