PMA
P160057: TRIVISC
FDA PMA · Acid, hyaluronic, intraarticular · Channel-Markers Medical, LLC
Key facts
| PMA number | P160057 |
|---|---|
| Trade name | TRIVISC |
| Generic name | Acid, hyaluronic, intraarticular |
| Applicant | Channel-Markers Medical, LLC |
| Owner/operator | Meiji Pharma Spain S.A. |
| Product code | MOZ |
| Approval date | Nov 13, 2017 |
| Docket number | 17M-6525 |
| Notice date | Nov 21, 2017 |
| Establishment registration | 3003184440 |
| FEI number | 3003184440 |
At a glance
- 1–9 Supplements
- May 20, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: