PMA P050047S078

Device
Juvéderm Injectable Gel Implants
Applicant
Allergan
PMA number
P050047
Supplement
S078
Product code
LMH
Decision date
2020-10-28
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Change to the cleaning method of process equipment used during the manufacturing of Juvéderm injectable gel products.

Current openFDA PMA Record#

Device
Juvéderm Injectable Gel Implants
Applicant
Allergan
PMA number
P050047
Supplement
S078
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-10-28
Decision code
OK30
Date received
2020-09-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the cleaning method of process equipment used during the manufacturing of Juvéderm injectable gel products.