PMA
P940004: ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI
FDA PMA · System, Test, Her-2/Neu, Nucleic Acid Or Serum · Ventana Medical Systems, Inc.
Key facts
| PMA number | P940004 |
|---|---|
| Trade name | ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI |
| Generic name | System, Test, Her-2/Neu, Nucleic Acid Or Serum |
| Applicant | Ventana Medical Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | MVD |
| Approval date | Dec 30, 1997 |
| Docket number | 98M-0712 |
| Notice date | Sep 9, 1998 |
| Establishment registration | 2028492 |
| FEI number | 1000125183 |
At a glance
- 1–9 Supplements
- Aug 1, 2000 Latest supplement decision
- Yes Withdrawn
- No 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: