PMA
P100027: INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
FDA PMA · Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer · Ventana Medical Systems, Inc.
Key facts
| PMA number | P100027 |
|---|---|
| Trade name | INFORM HER2 DUAL ISH DNA PROBE COCKTAIL |
| Generic name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer |
| Applicant | Ventana Medical Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | NYQ |
| Approval date | Jun 14, 2011 |
| Docket number | 11M-0472 |
| Notice date | Jun 15, 2011 |
| Establishment registration | 2028492 |
| FEI number | 1000125183 |
At a glance
- 10–99 Supplements
- Jan 26, 2024 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- No Withdrawn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: