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

• Device: VENTANA PD-L1 (SP263) Assay
• Applicant: Ventana 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 Received: 2022-10-14
• Decision Date: 2022-11-10
• PMA: P160046
• Supplement: S015
• Advisory Committee: Pathology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Ventana 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 Number	Date	Supplement Type
P160046		Original 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 ID	PMA	Supp
04015630972784	P160046	000