PMA P010029S041

Device: EUFLEXXA (1% SODIUM HYALURONATE)
Applicant: Ferring Pharmaceuticals, Inc.
PMA number: P010029
Supplement: S041
Product code: MOZ
Decision date: 2025-05-28
Classification: Orthopedic
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for the addition of an alternate 160L intermediate vessel and formulation capacity increase for 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: S041
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2025-05-28
Decision code: OK30
Date received: 2025-04-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of an alternate 160L intermediate vessel and formulation capacity increase for the manufacturing of the Euflexxa (1% sodium hyaluronate) product.