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.
Clean in place cycle changes and minor equipment modifications for the two large scale bulk formulation (lsbf) 10,000 l tanks and their associated filling transfer line within the fda approved pcr manufacturing center facility in branchburg, new jersey.
| Device | COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0 |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2010-11-08 |
| Decision Date | 2010-12-07 |
| PMA | P050028 |
| Supplement | S012 |
| 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 |
|---|---|---|
| P050028 | Original Filing | |
| S086 | 2022-10-21 | 30-day Notice |
| S085 | 2021-06-14 | 30-day Notice |
| S084 | 2021-02-23 | 30-day Notice |
| S083 | 2020-07-27 | 30-day Notice |
| S082 | 2020-04-17 | 30-day Notice |
| S081 | 2020-01-23 | 30-day Notice |
| S080 | 2019-10-08 | 30-day Notice |
| S079 | 2019-09-20 | 30-day Notice |
| S078 | 2019-08-16 | 30-day Notice |
| S077 | 2019-07-15 | Special (immediate Track) |
| S076 | 2019-04-24 | 30-day Notice |
| S075 | 2019-04-08 | 30-day Notice |
| S074 | 2019-03-20 | 30-day Notice |
| S073 | 2018-12-14 | 30-day Notice |
| S072 | 2018-11-13 | 30-day Notice |
| S071 | 2018-11-09 | 30-day Notice |
| S070 | 2018-08-21 | 30-day Notice |
| S069 | 2018-07-27 | 30-day Notice |
| S068 | 2018-06-29 | 30-day Notice |
| S067 | 2018-06-08 | 30-day Notice |
| S066 | 2018-06-04 | 30-day Notice |
| S065 | 2018-05-21 | 30-day Notice |
| S064 | 2018-04-16 | 30-day Notice |
| S063 | 2018-04-16 | 30-day Notice |
| S062 | 2018-04-16 | 30-day Notice |
| S061 | 2018-03-01 | 30-day Notice |
| S060 | 2017-11-14 | 30-day Notice |
| S059 | 2017-10-30 | 30-day Notice |
| S058 | 2017-09-26 | 30-day Notice |
| S057 | 2017-07-14 | 30-day Notice |
| S056 | 2017-07-14 | 30-day Notice |
| S055 | 2017-04-21 | Special (immediate Track) |
| S054 | 2016-09-22 | 30-day Notice |
| S053 | 2016-07-19 | 30-day Notice |
| S052 | 2016-07-08 | 30-day Notice |
| S051 | 2016-04-18 | 30-day Notice |
| S050 | 2016-04-07 | 30-day Notice |
| S049 | ||
| S048 | 2015-11-17 | Real-time Process |
| S047 | 2015-06-24 | 30-day Notice |
| S046 | 2015-04-09 | 30-day Notice |
| S045 | 2015-03-13 | 30-day Notice |
| S044 | 2015-02-25 | Real-time Process |
| S043 | 2014-12-19 | 30-day Notice |
| S042 | 2014-03-31 | 30-day Notice |
| S041 | 2014-03-18 | 30-day Notice |
| S040 | 2014-02-18 | 30-day Notice |
| S039 | 2013-12-26 | 30-day Notice |
| S038 | 2013-12-13 | 30-day Notice |
| S037 | 2013-09-09 | 30-day Notice |
| S036 | 2013-09-09 | 30-day Notice |
| S035 | 2013-08-14 | 30-day Notice |
| S034 | 2013-08-09 | 30-day Notice |
| S033 | 2013-05-28 | 30-day Notice |
| S032 | 2013-05-09 | 30-day Notice |
| S031 | 2013-04-08 | 30-day Notice |
| S030 | 2013-02-19 | Real-time Process |
| S029 | 2012-11-16 | Real-time Process |
| S028 | 2012-11-06 | Real-time Process |
| S027 | 2012-09-13 | 30-day Notice |
| S026 | 2012-08-15 | 30-day Notice |
| S025 | 2012-05-30 | Real-time Process |
| S024 | 2012-03-29 | Normal 180 Day Track No User Fee |
| S023 | 2011-12-12 | 135 Review Track For 30-day Notice |
| S022 | 2011-09-12 | 30-day Notice |
| S021 | 2011-09-01 | Special (immediate Track) |
| S020 | 2011-07-01 | Normal 180 Day Track |
| S019 | 2011-05-31 | Normal 180 Day Track No User Fee |
| S018 | ||
| S017 | 2011-03-08 | 135 Review Track For 30-day Notice |
| S016 | 2011-03-01 | 30-day Notice |
| S015 | 2011-03-01 | 135 Review Track For 30-day Notice |
| S014 | ||
| S013 | 2011-02-08 | 30-day Notice |
| S012 | 2010-11-08 | 30-day Notice |
| S011 | 2010-09-22 | 135 Review Track For 30-day Notice |
| S010 | ||
| S009 | ||
| S008 | 2010-08-05 | 30-day Notice |
| S007 | 2010-01-08 | 30-day Notice |
| S006 | 2009-12-24 | 30-day Notice |
| S005 | 2009-07-02 | 30-day Notice |
| S004 | 2009-07-01 | Normal 180 Day Track |
| S003 | 2008-12-05 | 30-day Notice |
| S002 | 2008-10-31 | 30-day Notice |
| S001 | 2008-10-06 | Real-time Process |