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.
| Device | VENTANA MMR RxDx Panel |
| Generic Name | Immunohistochemistry Test, Dna Mismatch Repair (mmr) Protein Assay |
| Applicant | Ventana 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 Received | 2022-04-28 |
| Decision Date | 2022-05-20 |
| PMA | P210001 |
| Supplement | S005 |
| Product Code | QNH |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ventana 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. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210001 | Original 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 |