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.
Manufacturing process change to use an alternate filter
| Device | cobas HPV Test |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2020-07-27 |
| Decision Date | 2020-08-26 |
| PMA | P190028 |
| Supplement | S002 |
| Product Code | MAQ |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190028 | Original Filing | |
| S006 | 2021-12-20 | 30-day Notice |
| S005 | 2021-05-18 | Special (immediate Track) |
| S004 | 2020-11-13 | 30-day Notice |
| S003 | 2020-09-17 | Special (immediate Track) |
| S002 | 2020-07-27 | 30-day Notice |
| S001 | 2020-04-10 | 30-day Notice |