DUROLANE
FDA premarket approval P170007/S002 · decided 2019-03-13
Approval details
- PMA number
- P170007
- Supplement
- S002
- 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
- 2019-02-06
- Decision date
- 2019-03-13
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Modification to a cleanroom utilized in the manufacture of DUROLANE.
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