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.
An update to the hazard information on the product labeling for kits on the cobas 6800/8800 systems.
| Device | cobas CMV |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. |
| Date Received | 2021-05-18 |
| Decision Date | 2021-06-02 |
| PMA | P160041 |
| Supplement | S033 |
| Product Code | PAB |
| 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 94588-2722 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160041 | Original Filing | |
| S035 | 2022-05-31 | Normal 180 Day Track |
| S034 | 2021-12-20 | 30-day Notice |
| S033 | 2021-05-18 | Special (immediate Track) |
| S032 | 2020-11-13 | 30-day Notice |
| S031 | 2020-09-17 | Special (immediate Track) |
| S030 | 2020-07-27 | 30-day Notice |
| S029 | 2020-04-17 | 30-day Notice |
| S028 | 2020-01-10 | 30-day Notice |
| S027 | 2019-11-29 | 30-day Notice |
| S026 | 2019-09-20 | 30-day Notice |
| S025 | 2019-08-30 | 30-day Notice |
| S024 | 2019-08-06 | 30-day Notice |
| S023 | ||
| S022 | 2019-05-09 | 30-day Notice |
| S021 | 2019-05-09 | 30-day Notice |
| S020 | 2019-04-24 | 30-day Notice |
| S019 | 2019-04-24 | 30-day Notice |
| S018 | 2019-04-10 | 30-day Notice |
| S017 | 2019-04-03 | 30-day Notice |
| S016 | 2018-12-14 | 30-day Notice |
| S015 | 2018-11-13 | 30-day Notice |
| S014 | 2018-11-09 | 30-day Notice |
| S013 | 2018-08-21 | 30-day Notice |
| S012 | 2018-07-27 | 30-day Notice |
| S011 | 2018-06-29 | 30-day Notice |
| S010 | 2018-06-08 | 30-day Notice |
| S009 | 2018-06-04 | 30-day Notice |
| S008 | 2018-04-16 | 30-day Notice |
| S007 | 2018-03-01 | 30-day Notice |
| S006 | 2018-02-22 | 30-day Notice |
| S005 | 2018-01-23 | 30-day Notice |
| S004 | 2017-11-22 | 30-day Notice |
| S003 | 2017-10-30 | 30-day Notice |
| S002 | 2017-09-26 | 30-day Notice |
| S001 | 2017-07-14 | 30-day Notice |