The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your premarket approval application (pma) 180-day supplement, which requested approval for expanding the indications for use to add the cobas® 6800/8800 systems (cobas® hpv) test to identify hpv positive patients.
| Device | CINtec PLUS Cytology |
| Generic Name | Immunocytochemistry Assay, P16/ki-67 |
| Applicant | Ventana Medical Systems, Inc. |
| Date Received | 2020-04-28 |
| Decision Date | 2020-08-14 |
| PMA | P190024 |
| Supplement | S001 |
| Product Code | QKF |
| 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. 1910 E Innovation Park Drive tucson, AZ 85755 |
Supplemental Filings
| 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 |
NIH GUDID Devices