VENTANA PD-L1 (SP263) Assay

FDA Premarket Approval P160046 S015

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 (SP263) Assay
ApplicantVentana Medical Systems, Inc.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP160046 Supplement NumberS015 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
PMAP160046
SupplementS015
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
tucson, AZ 85755 PMA NumberP160046 Supplement NumberS015 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
P160046Original Filing
S015 2022-10-14 30-day Notice
S014 2022-07-12 30-day Notice
S013
S012 2022-02-16 Special (immediate Track)
S011 2022-01-28 135 Review Track For 30-day Notice
S010 2021-06-14 Panel Track
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
S003
S002
S001 2017-07-17 30-day Notice

NIH GUDID Devices

Device IDPMASupp
04015630972784 P160046 000

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