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Device | Juvederm Voluma XC for Chin Augmentation |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P110033 |
Supplement Number | S047 |
Date Received | 06/20/2019 |
Decision Date | 06/12/2020 |
Product Code |
LMH |
Docket Number | 20M-1527 |
Notice Date | 06/16/2020 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT02833077
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the Juvéderm Voluma XC for expanding the indications to include chin augmentation. This device is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |