VENTANA PD-L1 (SP142) Assay

FDA Premarket Approval P160002 S019

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

DeviceVENTANA PD-L1 (SP142) Assay
ApplicantVENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP160002 Supplement NumberS019 Date Received10/14/2022 Decision Date11/10/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-14
Decision Date2022-11-10
PMAP160002
SupplementS019
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressVENTANA MEDICAL SYSTEMS, INC.
1910 East Innovation Park Dr.
tucson, AZ 85755 PMA NumberP160002 Supplement NumberS019 Date Received10/14/2022 Decision Date11/10/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
For Changes To A Manufacturing Process.

Supplemental Filings

Supplement NumberDateSupplement Type
P160002Original Filing
S019 2022-10-14 30-day Notice
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 2021-09-07 Special (immediate Track)
S014 2021-02-22 Real-time Process
S013 2020-08-26 Real-time Process
S012 2020-01-21 Normal 180 Day Track
S011 2020-01-13 Real-time Process
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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