PMA P990081S040
- Device
- PPATHWAY Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P990081
- Supplement
- S040
- Product code
- MVC
- Decision date
- 2019-05-06
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- Manufacturing process changes in Pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody.
Current openFDA PMA Record#
- Device
- PPATHWAY Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P990081
- Supplement
- S040
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2019-05-06
- Decision code
- OK30
- Date received
- 2019-04-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process changes in Pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody.