Ventana PD-Ll (SP142) Assay

Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1

FDA Premarket Approval P160002 S010

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 minor software and firmware updates for ventana system software on the benchmark ultra instruments.

DeviceVentana PD-Ll (SP142) Assay
Classification NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantVENTANA MEDICAL SYSTEMS, INC.
Date Received2019-08-22
Decision Date2019-11-19
PMAP160002
SupplementS010
Product CodePLS
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address VENTANA MEDICAL SYSTEMS, INC. 1910 East Innovation Park Dr. tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P160002Original Filing
S010 2019-08-22 Real-time Process
S009 2018-09-14 Panel Track
S008
S007 2018-06-18 Real-time Process
S006 2018-06-14 Normal 180 Day Track
S005
S004
S003 2017-07-17 30-day Notice
S002 2017-03-16 Normal 180 Day Track No User Fee
S001 2016-09-01 Normal 180 Day Track No User Fee

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