PMA
P190024: CINtec PLUS Cytology
FDA PMA · Immunocytochemistry assay, p16/Ki-67 · Ventana Medical Systems, Inc.
Key facts
| PMA number | P190024 |
|---|---|
| Trade name | CINtec PLUS Cytology |
| Generic name | Immunocytochemistry assay, p16/Ki-67 |
| Applicant | Ventana Medical Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | QKF |
| Approval date | Mar 10, 2020 |
| Docket number | 20M-1083 |
| Notice date | Mar 16, 2020 |
| Establishment registration | 2028492 |
| FEI number | 1000125183 |
At a glance
- 10–99 Supplements
- Sep 4, 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- No Withdrawn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: