PMA P100027S038
- Device
- INFORM HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S038
- Decision date
- 2022-11-10
- Approval order statement
- Changes to a manufacturing process.
Current openFDA PMA Record#
- Device
- INFORM HER2 Dual ISH DNA Probe Cocktail
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S038
- Decision date
- 2022-11-10
- Decision code
- OK30
- Date received
- 2022-10-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to a manufacturing process.