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.
| Device | Aptima HPV 16 18/45 Genotype Assay |
| Generic Name | Kit, Rna Detection, Human Papillomavirus |
| Applicant | GEN-PROBE INCORPORATED10210 Genetic Center Drivesan Diego, CA 92121 PMA NumberP120007 Supplement NumberS029 Date Received12/14/2021 Decision Date02/25/2022 Product Code OYB Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2021-12-14 |
| Decision Date | 2022-02-25 |
| PMA | P120007 |
| Supplement | S029 |
| 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 PMA NumberP120007 Supplement NumberS029 Date Received12/14/2021 Decision Date02/25/2022 Product Code OYB Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval To Support The Addition Of The Optional Use Of An Automated Dishwasher (Miele Dishwasher) To Wash Panther Trax Shuttle Shields, Sample Racks, And Storage Racks Used With The Aptima HPV Assays. |
| 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 |