PMA P050047S015

Device
JUVEDERM HYALURONATE GEL IMPLANTS
Applicant
Allergan
PMA number
P050047
Supplement
S015
Product code
LMH
Decision date
2011-03-25
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
APPROVAL FOR SOME LABELING UPDATES TO IMPROVE THE SAFE USE OF THE DEVICE.

Current openFDA PMA Record#

Device
JUVEDERM HYALURONATE GEL IMPLANTS
Applicant
Allergan
PMA number
P050047
Supplement
S015
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2011-03-25
Decision code
APPR
Date received
2011-03-09
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR SOME LABELING UPDATES TO IMPROVE THE SAFE USE OF THE DEVICE.