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.
Removal of raw material qc testing not relevant to the product.
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 | 2018-08-31 |
Decision Date | 2018-09-28 |
PMA | P120007 |
Supplement | S017 |
Product Code | OYB |
Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
Advisory Committee | Microbiology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
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 |