FDA Premarket Approval P160046 S009

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 dispenser resin replacement used in the injection molding process for six (6) dispenser parts.

DeviceVENTANA PD-LI (SP263) Assay
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantVentana Medical Systems, Inc.
Date Received2021-02-22
Decision Date2021-05-20
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
S009 2021-02-22 Real-time Process
S008 2020-08-26 Real-time Process
S007 2020-01-13 Real-time Process
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
S001 2017-07-17 30-day Notice

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