PMA P050047S081
- Device
- Juvéderm Hyaluronate Gel Implants
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S081
- Product code
- LMH
- Decision date
- 2021-06-23
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for additional incoming testing for the phosphate buffer solution used in the manufacture of the Juvéderm injectable gel implants.
Current openFDA PMA Record#
- Device
- Juvéderm Hyaluronate Gel Implants
- Applicant
- Allergan
- PMA number
- P050047
- Supplement
- S081
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-06-23
- Decision code
- APPR
- Date received
- 2021-05-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for additional incoming testing for the phosphate buffer solution used in the manufacture of the Juvéderm injectable gel implants.