DUROLANE
FDA premarket approval P170007/S014 · decided 2022-10-14
Approval details
- PMA number
- P170007
- Supplement
- S014
- 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
- 2022-09-14
- Decision date
- 2022-10-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Installation of a new point of use and a higher capacity centrifugal water pump for a Water for Injection (WFI) system used in the manufacturing of DUROLANE.
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|---|---|---|
| StimTrial Neuromodulation System (K243782) | Bioventus, LLC | 2025-07-16 |
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| Allograft Delivery Device (OFAC-C) (K233368) | Bioventus, LLC | 2024-06-25 |
| SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty (K233490) | Bioventus, LLC | 2023-12-05 |
| MCS Bone Graft (K162860) | Bioventus, LLC | 2017-02-13 |