TRIVISC
FDA premarket approval P160057 · decided 2017-11-13
Approval details
- PMA number
- P160057
- Trade name
- TRIVISC
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Channel-Markers Medical, LLC
- Date received
- 2016-12-23
- Decision date
- 2017-11-13
- Days to decision
- 325 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- Approval for TriVisc. The device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.