HYMOVIS
FDA premarket approval P150010 · decided 2015-08-28
Approval details
- PMA number
- P150010
- Trade name
- HYMOVIS
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Fidia Farmaceutici
- Date received
- 2015-02-25
- Decision date
- 2015-08-28
- Days to decision
- 184 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- Statement
- APPROVAL FOR HYMOVIS. THIS DEVICE 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 AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
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