Durolane
FDA premarket approval P170007/S013 · decided 2022-03-03
Approval details
- PMA number
- P170007
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Durolane
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Bioventus, LLC
- Date received
- 2022-02-03
- Decision date
- 2022-03-03
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Addition of an alternative supplier for sodium hydroxide and hydrochloric acid solutions used in the manufacturing of DUROLANE.
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| StimTrial Neuromodulation System (K243782) | Bioventus, LLC | 2025-07-16 |
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| MCS Bone Graft (K162860) | Bioventus, LLC | 2017-02-13 |