PMA P110033S021

Device: JUVEDERM VOLUMA XC
Applicant: Allergan
PMA number: P110033
Supplement: S021
Product code: LMH
Decision date: 2016-09-12
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
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.

Current openFDA PMA Record#

Device: JUVEDERM VOLUMA XC
Applicant: Allergan
PMA number: P110033
Supplement: S021
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2016-09-12
Decision code: APPR
Date received: 2016-03-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.