|
Device | JUVEDERM VOLUMA XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P110033 |
Supplement Number | S021 |
Date Received | 03/21/2016 |
Decision Date | 09/12/2016 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT01197495
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the labeling for Juvederm Voluma XC has been revised as follows: 1) to include the results of the completed post-approval study; 2) to include revisions to the postmarket surveillance summary; and 3) to include minor revisions intended to harmonize the directions with those of other Juvederm products. |