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.
Increase bulk manufacturing scale and modification of filling processes for critical reagents.
| Device | cobas CMV |
| Classification Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. |
| Date Received | 2019-08-30 |
| Decision Date | 2019-09-26 |
| PMA | P160041 |
| Supplement | S025 |
| Product Code | PAB |
| 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 94588-2722 |
| 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 |