VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

FDA Premarket Approval P200019 S004

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 MMR RxDx Panel (Endometrial Cancer with dMMR status)
Generic NameImmunohistochemistry Test, Dna Mismatch Repair (mmr) Protein Assay
ApplicantVentana Medical Systems1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP200019 Supplement NumberS004 Date Received02/16/2022 Decision Date07/21/2022 Product Code QNH  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-02-16
Decision Date2022-07-21
PMAP200019
SupplementS004
Product CodeQNH 
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressVentana Medical Systems
1910 E Innovation Park Drive
tucson, AZ 85755 PMA NumberP200019 Supplement NumberS004 Date Received02/16/2022 Decision Date07/21/2022 Product Code QNH  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For (i) A Change In Expiry Dating From Hematoxylin And Hematoxylin II And (ii) Implementation Of A Revised Process For Creating Reference Slides Used In Surveillance And Stability Testing Of Hematoxylin And Hematoxylin II

Supplemental Filings

Supplement NumberDateSupplement Type
P200019Original Filing
S005 2022-07-12 30-day Notice
S004 2022-02-16 Special (immediate Track)
S003 2022-01-28 135 Review Track For 30-day Notice
S002
S001

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