FDA.reportPublic FDA data

PMA P010029S030

Device
EUFLEXXA (1% Sodium Hyaluronate)
Applicant
Ferring Pharmaceuticals, Inc.
PMA number
P010029
Supplement
S030
Product code
MOZ
Decision date
2020-04-16
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Change in manufacturing to shorten the time required for the concentration step during formulation by slightly increasing the pressure and reducing the concentration time in the UF (ultrafiltration) unit.

Current openFDA PMA Record#

Device
EUFLEXXA (1% Sodium Hyaluronate)
Applicant
Ferring Pharmaceuticals, Inc.
PMA number
P010029
Supplement
S030
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2020-04-16
Decision code
OK30
Date received
2020-04-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in manufacturing to shorten the time required for the concentration step during formulation by slightly increasing the pressure and reducing the concentration time in the UF (ultrafiltration) unit.