PMA P010029S037

Device: EUFLEXXA
Applicant: Ferring Pharmaceuticals, Inc.
PMA number: P010029
Supplement: S037
Product code: MOZ
Decision date: 2024-03-01
Classification: Orthopedic
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: modifications to the purification process utilized in the manufacturing of NaHA bulk intermediate batches to optimize the ability to remove contaminants and to improve yield. Proposed modifications include increasing the amount of activated charcoal, Celatom and water for injection for the 1 kg and 1.5 kg batch sizes as well as two additional ethanol washes for the 1.5 kg batch size

Current openFDA PMA Record#

Device: EUFLEXXA
Applicant: Ferring Pharmaceuticals, Inc.
PMA number: P010029
Supplement: S037
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2024-03-01
Decision code: OK30
Date received: 2024-02-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modifications to the purification process utilized in the manufacturing of NaHA bulk intermediate batches to optimize the ability to remove contaminants and to improve yield. Proposed modifications include increasing the amount of activated charcoal, Celatom and water for injection for the 1 kg and 1.5 kg batch sizes as well as two additional ethanol washes for the 1.5 kg batch size