Approval for the ventana her2 dual ish dna probe cocktail assay.
| Device | 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. |
| Date Received | 2019-11-29 |
| Decision Date | 2020-07-28 |
| Notice Date | 2020-07-31 |
| PMA | P190031 |
| Supplement | S |
| Product Code | NYQ |
| Docket Number | 20M-1724 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ventana Medical Systems, Inc. 1910 E. Innovation Park Drive tucson, AZ 85755 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P190031 | | Original Filing |
| S005 |
2022-07-12 |
30-day Notice |
| S004 |
2022-02-16 |
Special (immediate Track) |
| S003 |
2022-01-28 |
135 Review Track For 30-day Notice |
| S002 |
2021-02-22 |
Real-time Process |
| S001 |
2020-08-26 |
Real-time Process |
NIH GUDID Devices