VENTANA ALK (D5F3) CDX ASSAY

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Premarket Approval P140025 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

DeviceVENTANA ALK (D5F3) CDX ASSAY
Classification NameImmunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
Generic NameImmunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
ApplicantVENTANA MEDICAL SYSTEMS, INC.
Date Received2015-12-10
Decision Date2016-04-13
PMAP140025
SupplementS002
Product CodePKW
Advisory CommitteePathology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address VENTANA MEDICAL SYSTEMS, INC. 1910 East Innovation Park Dr. tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P140025Original Filing
S018 2022-07-12 30-day Notice
S017 2022-02-16 Special (immediate Track)
S016 2022-01-28 135 Review Track For 30-day Notice
S015 2021-02-22 Real-time Process
S014 2020-11-16 Normal 180 Day Track
S013 2020-08-26 Real-time Process
S012 2020-01-13 Real-time Process
S011 2019-08-22 Real-time Process
S010 2018-11-09 30-day Notice
S009 2018-06-18 Real-time Process
S008
S007 2017-07-17 30-day Notice
S006 2017-06-07 Normal 180 Day Track
S005 2016-12-28 Normal 180 Day Track
S004 2016-11-15 Normal 180 Day Track
S003 2016-03-22 Normal 180 Day Track
S002 2015-12-10 135 Review Track For 30-day Notice
S001 2015-08-26 30-day Notice

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