DUROLOANE
FDA premarket approval P170007/S001 · decided 2018-08-17
Approval details
- PMA number
- P170007
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DUROLOANE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Bioventus, LLC
- Date received
- 2018-07-19
- Decision date
- 2018-08-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Replacement of a raw material supplier for a part used in the manufacture of DUROLANE.
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