PMA P990081S043
- Device
- PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P990081
- Supplement
- S043
- Product code
- MVC
- Decision date
- 2020-11-13
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- Approval for replacement of dispenser molds used in the injection molding process for six (6) dispenser parts.
Current openFDA PMA Record#
- Device
- PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P990081
- Supplement
- S043
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- 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 replacement of dispenser molds used in the injection molding process for six (6) dispenser parts.