PMA P020055S018

Device: VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S018
Product code: NKF
Decision date: 2016-04-13
Generic name: Immunohistochemistry antibody assay, c-kit
Approval order statement: Approval for the following:1) Enlargement of a bulk formulation room at Ventana Medical Systems' Tucson, AZ facility; and 2) addition of two large volume tanks, along with supply plumbing, a clean in place (CIP) procedure, and new filler, as well as a new fill line.

Current openFDA PMA Record#

Device: VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S018
Product code: NKF
Generic name: Immunohistochemistry antibody assay, c-kit
Decision date: 2016-04-13
Decision code: APPR
Date received: 2015-12-10
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the following:1) Enlargement of a bulk formulation room at Ventana Medical Systems' Tucson, AZ facility; and 2) addition of two large volume tanks, along with supply plumbing, a clean in place (CIP) procedure, and new filler, as well as a new fill line.