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 HER2 Dual ISH DNA Probe Cocktail |
| Generic Name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer |
| Applicant | Ventana Medical Systems, Inc.1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP190031 Supplement NumberS004 Date Received02/16/2022 Decision Date07/21/2022 Product Code NYQ 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 | P190031 |
| Supplement | S004 |
| Product Code | NYQ |
| 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, Inc. 1910 E. Innovation Park Drive tucson, AZ 85755 PMA NumberP190031 Supplement NumberS004 Date Received02/16/2022 Decision Date07/21/2022 Product Code NYQ 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 |
|---|---|---|
| P190031 | Original Filing | |
| 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 | 2021-02-22 | Real-time Process |
| S001 | 2020-08-26 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 07613336158432 | P190031 | 000 |