|Trade Name||JUVEDERM VOLUMA XC|
|Classification Name||implant, dermal, for aesthetic use|
||General & Plastic Surgery
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the unit of measurement for gel to be mixed and a change to the in process concentration of the lidocaine solution mixed into the gel during homogenization.