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.
Changes in manufacturing gowning procedures
| Device | COBAS® AmliPrep/COBAS® TaqMan® CMV Test |
| Classification Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2019-04-24 |
| Decision Date | 2019-05-22 |
| PMA | P110037 |
| Supplement | S047 |
| 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 |
|---|---|---|
| P110037 | Original Filing | |
| S057 | 2022-10-21 | 30-day Notice |
| S056 | 2021-06-14 | 30-day Notice |
| S055 | 2021-02-23 | 30-day Notice |
| S054 | 2020-07-27 | 30-day Notice |
| S053 | 2020-04-17 | 30-day Notice |
| S052 | 2020-01-23 | 30-day Notice |
| S051 | 2019-10-08 | 30-day Notice |
| S050 | 2019-09-20 | 30-day Notice |
| S049 | 2019-08-16 | 30-day Notice |
| S048 | 2019-07-15 | Special (immediate Track) |
| S047 | 2019-04-24 | 30-day Notice |
| S046 | 2019-04-10 | 30-day Notice |
| S045 | 2019-03-20 | 30-day Notice |
| S044 | 2018-12-14 | 30-day Notice |
| S043 | 2018-11-13 | 30-day Notice |
| S042 | 2018-11-09 | 30-day Notice |
| S041 | 2018-08-21 | 30-day Notice |
| S040 | 2018-07-27 | 30-day Notice |
| S039 | 2018-06-29 | 30-day Notice |
| S038 | 2018-06-08 | 30-day Notice |
| S037 | 2018-06-04 | 30-day Notice |
| S036 | 2018-04-16 | 30-day Notice |
| S035 | 2018-04-16 | 30-day Notice |
| S034 | 2018-03-01 | 30-day Notice |
| S033 | 2017-11-14 | 30-day Notice |
| S032 | 2017-09-26 | 30-day Notice |
| S031 | 2017-07-14 | 30-day Notice |
| S030 | 2017-07-14 | 30-day Notice |
| S029 | 2016-09-22 | 30-day Notice |
| S028 | 2016-07-19 | 30-day Notice |
| S027 | 2016-07-08 | 30-day Notice |
| S026 | 2016-04-18 | 30-day Notice |
| S025 | 2016-04-07 | 30-day Notice |
| S024 | 2015-11-17 | Real-time Process |
| S023 | 2015-10-22 | Normal 180 Day Track |
| S022 | 2015-06-24 | 30-day Notice |
| S021 | 2015-04-09 | 30-day Notice |
| S020 | 2015-03-13 | 30-day Notice |
| S019 | 2015-02-25 | Real-time Process |
| S018 | 2014-12-19 | 30-day Notice |
| S017 | 2014-12-19 | 30-day Notice |
| S016 | 2014-12-16 | Real-time Process |
| S015 | 2014-03-31 | 30-day Notice |
| S014 | 2014-03-18 | 30-day Notice |
| S013 | 2014-02-18 | 30-day Notice |
| S012 | 2013-10-30 | 30-day Notice |
| S011 | 2013-09-09 | 30-day Notice |
| S010 | 2013-09-09 | 30-day Notice |
| S009 | 2013-08-14 | 30-day Notice |
| S008 | 2013-08-09 | 30-day Notice |
| S007 | 2013-07-26 | 30-day Notice |
| S006 | 2013-05-09 | 30-day Notice |
| S005 | 2013-02-19 | Special (immediate Track) |
| S004 | 2012-11-16 | Real-time Process |
| S003 | 2012-11-02 | Real-time Process |
| S002 | 2012-08-15 | 30-day Notice |
| S001 | 2012-08-07 | Real-time Process |