PMA P150010S005

Device: HYMOVIS ONE
Applicant: Fidia Farmaceutici
PMA number: P150010
Supplement: S005
Product code: MOZ
Decision date: 2025-04-09
Classification: Orthopedic
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).

Current openFDA PMA Record#

Device: HYMOVIS ONE
Applicant: Fidia Farmaceutici
PMA number: P150010
Supplement: S005
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2025-04-09
Decision code: APPR
Date received: 2024-12-23
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).