PMA
P220016: HepQuant SHUNT® Liver Diagnostic Test
FDA PMA · Test for Esophageal Varices · Hepquant, LLC
Key facts
| PMA number | P220016 |
|---|---|
| Trade name | HepQuant SHUNT® Liver Diagnostic Test |
| Generic name | Test for Esophageal Varices |
| Applicant | Hepquant, LLC |
| Product code | SIO |
| Approval date | Jun 18, 2026 |
| Docket number | FDA-6931 |
| Notice date | Jun 23, 2026 |
At a glance
- None Supplements
- Jun 18, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: