HYMOVIS ONE
FDA premarket approval P150010/S005 · decided 2025-04-09
Approval details
- PMA number
- P150010
- Supplement
- S005
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HYMOVIS ONE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Fidia Farmaceutici
- Date received
- 2024-12-23
- Decision date
- 2025-04-09
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- 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).
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