PMA P160002S018

Device
VENTANA PD-L1 (SP142) Assay
Applicant
Ventana Medical Systems, Inc.
PMA number
P160002
Supplement
S018
Decision date
2022-07-29
Approval order statement
Addition of alternative suppliers for component parts.

Current openFDA PMA Record#

Device
VENTANA PD-L1 (SP142) Assay
Applicant
Ventana Medical Systems, Inc.
PMA number
P160002
Supplement
S018
Decision date
2022-07-29
Decision code
OK30
Date received
2022-07-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of alternative suppliers for component parts.