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.
The sponsor has proposed changes to the products identified above as the outcome of periodic internal reviews of hazard information. Per the sponsor, hazard information is compared against the most current safety data sheet to confirm whether any updates are reflected in product labeling. The sponsor notes that updates to the product hazard information strengthen instructions to enhance the safe use of the device. Review of the redlined versions of labeling, included in the submission, confirms that there are no changes to product formulation or changes to how the user interacts with the product. The changes do not pose any safety or efficacy concerns and accordingly are acceptable.
| Device | cobas HPV |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2020-09-17 |
| Decision Date | 2020-10-07 |
| PMA | P190028 |
| Supplement | S003 |
| Product Code | MAQ |
| Advisory Committee | Microbiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |