PMA
P200019: VENTANA MMR RxDx Panel
FDA PMA · Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay · Ventana Medical Systems
Key facts
| PMA number | P200019 |
|---|---|
| Trade name | VENTANA MMR RxDx Panel |
| Generic name | Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay |
| Applicant | Ventana Medical Systems |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | QNH |
| Approval date | Apr 22, 2021 |
| Docket number | 21M-0416 |
| Notice date | Apr 29, 2021 |
| Establishment registration | 2028492 |
| FEI number | 1000125183 |
At a glance
- 10–99 Supplements
- Oct 8, 2026 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- No Withdrawn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: