PMA P010029

Device
EUFLEXXA® (1% SODIUM HYALURONATE)
Applicant
Ferring Pharmaceuticals, Inc.
PMA number
P010029
Supplement
S030
Product code
MOZ
Decision date
2025-10-16
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Approval for replacement of the autoclave used for sterilization of the filling machine parts.

Current openFDA PMA Record#

Device
EUFLEXXA® (1% SODIUM HYALURONATE)
Applicant
Ferring Pharmaceuticals, Inc.
PMA number
P010029
Supplement
S042
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2025-10-16
Decision code
OK30
Date received
2025-09-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for replacement of the autoclave used for sterilization of the filling machine parts.