Durolane
FDA premarket approval P170007/S004 · decided 2019-09-19
Approval details
- PMA number
- P170007
- Supplement
- S004
- 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
- 2019-08-20
- Decision date
- 2019-09-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Extension of the designated shelf life of the HA raw material used in the manufacture of Durolane.
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