Ventana PD-Ll (SP263) Assay

Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1

FDA Premarket Approval P160046 S006

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 (SP263) 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
PMAP160046
SupplementS006
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 E. Innovation Park Dr. tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P160046Original Filing
S006 2019-08-22 Real-time Process
S005 2018-06-18 Real-time Process
S004 2018-04-03 Normal 180 Day Track No User Fee
S003
S002
S001 2017-07-17 30-day Notice

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