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 NumberS001 Date Received08/18/2021 Decision Date03/21/2022 Product Code QNH Advisory Committee Pathology Clinical TrialsNCT02460198 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2021-08-18 |
| Decision Date | 2022-03-21 |
| PMA | P210001 |
| Supplement | S001 |
| Product Code | QNH |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 NumberS001 Date Received08/18/2021 Decision Date03/21/2022 Product Code QNH Advisory Committee Pathology Clinical TrialsNCT02460198 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For The Ventana MMR RxDx Panel As A CDx For Identifying Patients With Solid Tumors With DMMR Status Who May Benefit From Treatment With KEYTRUDA. |
| 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 |