FDA.reportPublic FDA data

PMA P050047S052

Device
JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS
Applicant
Allergan
PMA number
P050047
Supplement
S052
Product code
LMH
Decision date
2016-04-29
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for changes to the Directions for Use and Patient Labeling including updated postmarket surveillance data as well as other changes to harmonize pertinent content across Juvederm labeling documents. Minor typographical revisions and clarifications are also included.

Current openFDA PMA Record#

Device
JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS
Applicant
Allergan
PMA number
P050047
Supplement
S052
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2016-04-29
Decision code
APPR
Date received
2016-04-04
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for changes to the Directions for Use and Patient Labeling including updated postmarket surveillance data as well as other changes to harmonize pertinent content across Juvederm labeling documents. Minor typographical revisions and clarifications are also included.