PMA P010029S028

Device
EUFLEXXA (1% Sodium Hyaluronate)
Applicant
Ferring Pharmaceuticals, Inc.
PMA number
P010029
Supplement
S028
Product code
MOZ
Decision date
2019-05-08
Classification
Acid, Hyaluronic, Intraarticular
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Addition of an alternative supplier of the syringes used to inject EUFLEXXA.

Current openFDA PMA Record#

Device
EUFLEXXA (1% Sodium Hyaluronate)
Applicant
Ferring Pharmaceuticals, Inc.
PMA number
P010029
Supplement
S028
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2019-05-08
Decision code
OK30
Date received
2019-04-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternative supplier of the syringes used to inject EUFLEXXA.