DUROLANE
FDA premarket approval P170007 · decided 2017-08-29
Approval details
- PMA number
- P170007
- Trade name
- DUROLANE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Bioventus, LLC
- Date received
- 2017-03-02
- Decision date
- 2017-08-29
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR DUROLANE. THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGICAL THERAPY OR SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
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