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 (Endometrial Cancer with dMMR status) |
| Generic Name | Immunohistochemistry Test, Dna Mismatch Repair (mmr) Protein Assay |
| Applicant | Ventana Medical Systems1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP200019 Supplement NumberS004 Date Received02/16/2022 Decision Date07/21/2022 Product Code QNH Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-02-16 |
| Decision Date | 2022-07-21 |
| PMA | P200019 |
| Supplement | S004 |
| Product Code | QNH |
| Advisory Committee | Pathology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ventana Medical Systems 1910 E Innovation Park Drive tucson, AZ 85755 PMA NumberP200019 Supplement NumberS004 Date Received02/16/2022 Decision Date07/21/2022 Product Code QNH Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For (i) A Change In Expiry Dating From Hematoxylin And Hematoxylin II And (ii) Implementation Of A Revised Process For Creating Reference Slides Used In Surveillance And Stability Testing Of Hematoxylin And Hematoxylin II |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200019 | Original Filing | |
| S006 | 2022-10-14 | 30-day Notice |
| S005 | 2022-07-12 | 30-day Notice |
| S004 | 2022-02-16 | Special (immediate Track) |
| S003 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S002 | ||
| S001 |