PMA P110033S053
- Device
- Juvederm Volbella XC
- Applicant
- Allergan
- Product code
- LMH
- Decision date
- 2021-05-28
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for JUVEDERM VOLBELLA XC for expanding the indications to include the improvement of infraorbital hollowing in adults over the age of 21.
Current openFDA PMA Record#
- Device
- Juvederm Volbella XC
- Applicant
- Allergan
- PMA number
- P110033
- Supplement
- S053
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-05-28
- Decision code
- APPR
- Date received
- 2020-03-30
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for JUVEDERM VOLBELLA XC for expanding the indications to include the improvement of infraorbital hollowing in adults over the age of 21.