PMA P110033S060

Device
Juvéderm Hyaluronate Gel Implants
Applicant
Allergan
PMA number
P110033
Supplement
S060
Product code
LMH
Decision date
2021-06-23
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for additional incoming testing for the phosphate buffer solution used in the manufacture of the Juvéderm injectable gel implants.

Current openFDA PMA Record#

Device
Juvéderm Hyaluronate Gel Implants
Applicant
Allergan
PMA number
P110033
Supplement
S060
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2021-06-23
Decision code
APPR
Date received
2021-05-27
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for additional incoming testing for the phosphate buffer solution used in the manufacture of the Juvéderm injectable gel implants.