VENTANA MMR RxDx Panel (Solid Tumors with dMMR status)

FDA Premarket Approval P210001 S007

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 (Solid Tumors with dMMR status)
ApplicantVentana Medical Systems Inc (Roche Tissue Diagnostics)1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP210001 Supplement NumberS007 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
PMAP210001
SupplementS007
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressVentana Medical Systems Inc (Roche Tissue Diagnostics)
1910 E. Innovation Park Drive
tucson, AZ 85755 PMA NumberP210001 Supplement NumberS007 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
P210001Original Filing
S007 2022-10-14 30-day Notice
S006 2022-07-12 30-day Notice
S005 2022-04-28 Normal 180 Day Track No User Fee
S004
S003
S002
S001 2021-08-18 Normal 180 Day Track

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