PMA P050047S070

Device
Juvéderm Injectable Gel Implants
Applicant
Allergan
PMA number
P050047
Supplement
S070
Product code
LMH
Decision date
2019-05-10
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Implementation of an additional identical tank used to manufacture high molecular weight hyaluronic acid (HA) at the raw material supplier.

Current openFDA PMA Record#

Device
Juvéderm Injectable Gel Implants
Applicant
Allergan
PMA number
P050047
Supplement
S070
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2019-05-10
Decision code
OK30
Date received
2019-04-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an additional identical tank used to manufacture high molecular weight hyaluronic acid (HA) at the raw material supplier.