|
Device | JUVEDERM VOLBELLA XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P110033 |
Supplement Number | S018 |
Date Received | 08/03/2015 |
Decision Date | 05/31/2016 |
Product Code |
LMH |
Docket Number | 16M-1401 |
Notice Date | 06/02/2016 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT01998581
|
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for JUVÉDERM VOLBELLA® XC injectable gel. The device is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |