PMA P050047S053

Device
JUVEDERM Hyaluronate Gel Implants
Applicant
Allergan
PMA number
P050047
Supplement
S053
Product code
LMH
Decision date
2016-05-26
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Authorization for the implementation of new equipment for scale-up of Juvederm manufacturing processes.

Current openFDA PMA Record#

Device
JUVEDERM Hyaluronate Gel Implants
Applicant
Allergan
PMA number
P050047
Supplement
S053
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2016-05-26
Decision code
OK30
Date received
2016-05-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Authorization for the implementation of new equipment for scale-up of Juvederm manufacturing processes.