DUROLANE
FDA premarket approval P170007/S007 · decided 2020-11-29
Approval details
- PMA number
- P170007
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DUROLANE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Bioventus, LLC
- Date received
- 2020-09-01
- Decision date
- 2020-11-29
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Approval for the addition of a second supplier of the sodium hyaluronate raw material used in the manufacture of DUROLANE.
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