PMA P050047

Device
Juvéderm Ultra XC, and Juvéderm Ultra Plus XC (hereafter referred to as Ultra XC and Ultra Plus XC)
Applicant
Allergan
PMA number
P050047
Supplement
S086
Product code
LMH
Decision date
2025-08-14
Generic name
Implant, dermal, for aesthetic use
Approval order statement
to update the varnish used in the manufacture of Juvederm carton boxes

Current openFDA PMA Record#

Device
Juvéderm Ultra XC, and Juvéderm Ultra Plus XC (hereafter referred to as Ultra XC and Ultra Plus XC)
Applicant
Allergan
PMA number
P050047
Supplement
S105
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2025-08-14
Decision code
OK30
Date received
2025-07-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to update the varnish used in the manufacture of Juvederm carton boxes