VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

FDA Premarket Approval P200019 S003

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 NumberS003 Date Received01/28/2022 Decision Date06/10/2022 Product Code QNH  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-01-28
Decision Date2022-06-10
PMAP200019
SupplementS003
Product CodeQNH 
Advisory CommitteePathology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressVentana Medical Systems
1910 E Innovation Park Drive
tucson, AZ 85755 PMA NumberP200019 Supplement NumberS003 Date Received01/28/2022 Decision Date06/10/2022 Product Code QNH  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
addition Of Two New Contract Manufacturers As Approved Suppliers For Component Parts

Supplemental Filings

Supplement NumberDateSupplement Type
P200019Original Filing
S003 2022-01-28 135 Review Track For 30-day Notice
S002
S001

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