PMA P010029S029

Device: Euflexxa (1% Sodium Hyaluronate)
Applicant: Ferring Pharmaceuticals, Inc.
PMA number: P010029
Supplement: S029
Product code: MOZ
Decision date: 2020-01-02
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Elimination of syringeability testing from finished product testing, and the elimination of the syringeability test parameter from EUFLEXXA release and stability test parameters.

Current openFDA PMA Record#

Device: Euflexxa (1% Sodium Hyaluronate)
Applicant: Ferring Pharmaceuticals, Inc.
PMA number: P010029
Supplement: S029
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2020-01-02
Decision code: OK30
Date received: 2019-12-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Elimination of syringeability testing from finished product testing, and the elimination of the syringeability test parameter from EUFLEXXA release and stability test parameters.