VENTANA MMR RxDx Panel

FDA Premarket Approval P210001 S005

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
Generic NameImmunohistochemistry Test, Dna Mismatch Repair (mmr) Protein Assay
ApplicantVentana Medical Systems Inc (Roche Tissue Diagnostics)1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP210001 Supplement NumberS005 Date Received04/28/2022 Decision Date05/20/2022 Product Code QNH  Advisory Committee Pathology Clinical TrialsNCT02628067 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-04-28
Decision Date2022-05-20
PMAP210001
SupplementS005
Product CodeQNH 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressVentana Medical Systems Inc (Roche Tissue Diagnostics)
1910 E. Innovation Park Drive
tucson, AZ 85755 PMA NumberP210001 Supplement NumberS005 Date Received04/28/2022 Decision Date05/20/2022 Product Code QNH  Advisory Committee Pathology Clinical TrialsNCT02628067
Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval Of The Clinical Protocol Entitled Statistical Analysis Plan For MK-3475 DMMR VENTANA MMR RxDx Panel Post Approval Analysis.

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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