PMA P010029S036

Device: EUFLEXXA® (1% sodium hyaluronate)
Applicant: Ferring Pharmaceuticals, Inc.
PMA number: P010029
Supplement: S036
Product code: MOZ
Decision date: 2024-02-02
Classification: Orthopedic
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for introduction of new silicone gaskets for ceramic membranes of the Ultrafiltration (UF3) formulation and filling unit used in the manufacturing of the Euflexxa (1% sodium hyaluronate) product.

Current openFDA PMA Record#

Device: EUFLEXXA® (1% sodium hyaluronate)
Applicant: Ferring Pharmaceuticals, Inc.
PMA number: P010029
Supplement: S036
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2024-02-02
Decision code: APPR
Date received: 2023-08-30
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for introduction of new silicone gaskets for ceramic membranes of the Ultrafiltration (UF3) formulation and filling unit used in the manufacturing of the Euflexxa (1% sodium hyaluronate) product.