PMA P110033S037

Device
Juvederm Injectable Gel Implants
Applicant
Allergan
PMA number
P110033
Supplement
S037
Product code
LMH
Decision date
2018-04-05
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Addition of a new syringe assembly and packaging line, its associated cleanroom, and minor aesthetic changes to the syringe finger grip and plunger rod.

Current openFDA PMA Record#

Device
Juvederm Injectable Gel Implants
Applicant
Allergan
PMA number
P110033
Supplement
S037
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2018-04-05
Decision code
OK30
Date received
2018-03-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a new syringe assembly and packaging line, its associated cleanroom, and minor aesthetic changes to the syringe finger grip and plunger rod.