PMA P010029S040

Device: EUFLEXXA
Applicant: Ferring Pharmaceuticals, Inc.
PMA number: P010029
Supplement: S040
Product code: MOZ
Decision date: 2024-09-23
Classification: Orthopedic
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for introduction of a new 1 ?m filter to be used during the second step of the bulk intermediate purification process for the manufacturing of the Euflexxa (1% sodium hyaluronate) product.

Current openFDA PMA Record#

Device: EUFLEXXA
Applicant: Ferring Pharmaceuticals, Inc.
PMA number: P010029
Supplement: S040
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2024-09-23
Decision code: OK30
Date received: 2024-08-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for introduction of a new 1 ?m filter to be used during the second step of the bulk intermediate purification process for the manufacturing of the Euflexxa (1% sodium hyaluronate) product.