DUROLANE
FDA premarket approval P170007/S006 · decided 2020-10-08
Approval details
- PMA number
- P170007
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DUROLANE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Bioventus, LLC
- Date received
- 2020-04-29
- Decision date
- 2020-10-08
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Approval for the removal of testing of heavy metals in raw materials for DUROLANE as per USP<231> and replacing it by a risk analysis on the final product based on ICH Q3D Guideline for Elemental Impurities.
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