PMA P050047S074

Device
Juvederm Injectable Gel Implants
Applicant
Allergan
PMA number
P050047
Supplement
S074
Product code
LMH
Decision date
2019-12-03
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Implementation of an additional cold room at the Pringy II manufacturing facility for the storage of raw materials for Juvéderm® injectable gel implants.

Current openFDA PMA Record#

Device
Juvederm Injectable Gel Implants
Applicant
Allergan
PMA number
P050047
Supplement
S074
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2019-12-03
Decision code
OK30
Date received
2019-11-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an additional cold room at the Pringy II manufacturing facility for the storage of raw materials for Juvéderm® injectable gel implants.