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 | CINtec PLUS Cytology |
| Generic Name | Immunocytochemistry Assay, P16/ki-67 |
| Applicant | Ventana Medical Systems, Inc.1910 E Innovation Park Drivetucson, AZ 85755 PMA NumberP190024 Supplement NumberS009 Date Received01/03/2023 Decision Date01/30/2023 Product Code QKF Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2023-01-03 |
| Decision Date | 2023-01-30 |
| PMA | P190024 |
| Supplement | S009 |
| Product Code | QKF |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ventana Medical Systems, Inc. 1910 E Innovation Park Drive tucson, AZ 85755 PMA NumberP190024 Supplement NumberS009 Date Received01/03/2023 Decision Date01/30/2023 Product Code QKF Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Changes To A Manufacturing Process. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190024 | Original Filing | |
| S009 | 2023-01-03 | 30-day Notice |
| S008 | 2022-10-14 | 30-day Notice |
| S007 | 2022-07-12 | 30-day Notice |
| S006 | 2022-02-16 | Special (immediate Track) |
| S005 | 2022-01-28 | 135 Review Track For 30-day Notice |
| S004 | 2021-03-01 | 30-day Notice |
| S003 | ||
| S002 | 2020-08-26 | Real-time Process |
| S001 | 2020-04-28 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 04015630977215 | P190024 | 000 |