PMA P110033S012

Device
JUVEDERM VOLUMA XC
Applicant
Allergan
PMA number
P110033
Supplement
S012
Product code
LMH
Decision date
2014-11-19
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
APPROVAL FOR THE ADDITION OF A PRECAUTION REGARDING COMPLIANCE WITH NEEDLE ATTACHMENT INSTRUCTIONS.

Current openFDA PMA Record#

Device
JUVEDERM VOLUMA XC
Applicant
Allergan
PMA number
P110033
Supplement
S012
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2014-11-19
Decision code
APPR
Date received
2014-11-03
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR THE ADDITION OF A PRECAUTION REGARDING COMPLIANCE WITH NEEDLE ATTACHMENT INSTRUCTIONS.