|
Device | Juvéderm Volux XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P110033 |
Supplement Number | S065 |
Date Received | 08/30/2021 |
Decision Date | 07/29/2022 |
Product Code |
LMH |
Docket Number | 22M-1793 |
Notice Date | 08/04/2022 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT03712137
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approved for the indication of subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |