PMA P990081S052
- Device
- PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P990081
- Supplement
- S052
- Product code
- MVC
- Decision date
- 2023-11-08
- Classification
- Pathology
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- addition of an alternative supplier for dispenser component 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
- S052
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2023-11-08
- Decision code
- OK30
- Date received
- 2023-10-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of an alternative supplier for dispenser component parts