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 | Oncomine Dx Target Test |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS037 Date Received06/14/2022 Decision Date09/19/2022 Product Code PQP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-06-14 |
| Decision Date | 2022-09-19 |
| PMA | P160045 |
| Supplement | S037 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LIFE TECHNOLOGIES CORPORATION 5781 Van Allen Way carlsbad, CA 92008 PMA NumberP160045 Supplement NumberS037 Date Received06/14/2022 Decision Date09/19/2022 Product Code PQP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For The Revised DNA And RNA Controls (DNA Control V3 And RNA Control V2) For The Oncomine Dx Target Test |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160045 | Original Filing | |
| S038 | 2022-08-05 | Normal 180 Day Track No User Fee |
| S037 | 2022-06-14 | Real-time Process |
| S036 | 2022-03-29 | 135 Review Track For 30-day Notice |
| S035 | 2022-03-08 | Panel Track |
| S034 | 2021-12-23 | Normal 180 Day Track No User Fee |
| S033 | ||
| S032 | ||
| S031 | ||
| S030 | 2021-05-14 | 30-day Notice |
| S029 | ||
| S028 | ||
| S027 | ||
| S026 | ||
| S025 | ||
| S024 | 2020-11-06 | 30-day Notice |
| S023 | 2020-10-01 | 30-day Notice |
| S022 | 2020-09-11 | 30-day Notice |
| S021 | ||
| S020 | 2020-05-14 | 30-day Notice |
| S019 | ||
| S018 | 2019-10-16 | 30-day Notice |
| S017 | ||
| S016 | 2019-07-22 | 30-day Notice |
| S015 | 2019-04-23 | 30-day Notice |
| S014 | 2019-01-31 | 30-day Notice |
| S013 | 2019-01-25 | 30-day Notice |
| S012 | 2018-11-13 | 30-day Notice |
| S011 | 2018-10-19 | 30-day Notice |
| S010 | 2018-10-09 | 30-day Notice |
| S009 | ||
| S008 | 2018-07-20 | 30-day Notice |
| S007 | ||
| S006 | 2018-05-02 | 30-day Notice |
| S005 | 2018-03-22 | Normal 180 Day Track No User Fee |
| S004 | ||
| S003 | 2017-11-20 | 30-day Notice |
| S002 | 2017-11-08 | 30-day Notice |
| S001 | 2017-07-28 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 10190302015103 | P160045 | 000 |
| 10190302006156 | P160045 | 000 |
| 10190302006095 | P160045 | 000 |
| 10190302006064 | P160045 | 000 |
| 10190302015646 | P160045 | 000 |
| 10190302006071 | P160045 | 000 |
| 10190302017756 | P160045 | 000 |