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.
Approval to revise the release criteria for specificity testing of the negative qc panel internal control rlu parameter
Device | Aptima HPV 16 18/45 Genotype Assay |
Classification Name | Kit, Rna Detection, Human Papillomavirus |
Generic Name | Kit, Rna Detection, Human Papillomavirus |
Applicant | GEN-PROBE INCORPORATED |
Date Received | 2019-03-01 |
Decision Date | 2019-04-22 |
PMA | P120007 |
Supplement | S019 |
Product Code | OYB |
Advisory Committee | Microbiology |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | GEN-PROBE INCORPORATED 10210 Genetic Center Drive san Diego, CA 92121 |
Supplement Number | Date | Supplement Type |
---|---|---|
P120007 | Original Filing | |
S029 | 2021-12-14 | Real-time Process |
S028 | 2020-07-09 | 30-day Notice |
S027 | 2020-05-14 | 30-day Notice |
S026 | 2019-12-23 | Real-time Process |
S025 | ||
S024 | 2019-08-21 | 30-day Notice |
S023 | 2019-08-02 | 30-day Notice |
S022 | ||
S021 | 2019-03-27 | 30-day Notice |
S020 | 2019-03-18 | Real-time Process |
S019 | 2019-03-01 | Real-time Process |
S018 | 2018-12-31 | Real-time Process |
S017 | 2018-08-31 | 30-day Notice |
S016 | 2018-08-16 | 30-day Notice |
S015 | 2018-03-15 | 30-day Notice |
S014 | 2018-02-08 | 30-day Notice |
S013 | 2017-12-20 | 30-day Notice |
S012 | 2017-10-10 | 30-day Notice |
S011 | 2017-09-01 | Normal 180 Day Track |
S010 | 2017-03-17 | Real-time Process |
S009 | 2016-08-15 | 30-day Notice |
S008 | 2016-03-01 | 30-day Notice |
S007 | 2015-10-16 | 30-day Notice |
S006 | 2015-08-28 | 135 Review Track For 30-day Notice |
S005 | ||
S004 | 2015-03-04 | 30-day Notice |
S003 | 2014-12-24 | Normal 180 Day Track No User Fee |
S002 | 2014-04-17 | Real-time Process |
S001 | 2013-05-15 | Normal 180 Day Track |