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.
A scale-up of reagents
| Device | Aptima HPV 16 18/45 Genotype Assay |
| Generic Name | Kit, Rna Detection, Human Papillomavirus |
| Applicant | GEN-PROBE INCORPORATED |
| Date Received | 2020-05-14 |
| Decision Date | 2020-06-11 |
| PMA | P120007 |
| Supplement | S027 |
| Product Code | OYB |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 15420045500136 | P120007 | 001 |
| 15420045500129 | P120007 | 001 |
| 15420045500112 | P120007 | 001 |