TriVisc
FDA premarket approval P160057/S003 · decided 2025-05-20
Approval details
- PMA number
- P160057
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TriVisc
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Channel-Markers Medical, LLC
- Date received
- 2025-05-05
- Decision date
- 2025-05-20
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- Addition of an alternate supplier of bulk sodium hyaluronate (HA) raw material for GenVisc 850 and Trivisc
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