- Device
- VENTANA HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P190031
- Supplement
- S001
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2020-11-13
- Decision code
- APPR
- Date received
- 2020-08-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the replacement of dispenser molds used in the injection molding process for six (6) dispenser parts.