Durolane, Hyaluronic Acid, Stabilized Single Injection
FDA premarket approval P170007/S003 · decided 2019-06-08
Approval details
- PMA number
- P170007
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Durolane, Hyaluronic Acid, Stabilized Single Injection
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Bioventus, LLC
- Date received
- 2019-05-09
- Decision date
- 2019-06-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Alternative source of the sodium chloride solution utilized in the manufacture of DUROLANE.
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