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 NumberS038 Date Received08/05/2022 Decision Date02/01/2023 Product Code PQP Advisory Committee Pathology Clinical TrialsNCT02609776 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No |
| Date Received | 2022-08-05 |
| Decision Date | 2023-02-01 |
| PMA | P160045 |
| Supplement | S038 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LIFE TECHNOLOGIES CORPORATION 5781 Van Allen Way carlsbad, CA 92008 PMA NumberP160045 Supplement NumberS038 Date Received08/05/2022 Decision Date02/01/2023 Product Code PQP Advisory Committee Pathology Clinical TrialsNCT02609776 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval To Update The User Guide For The Oncomine Dx Target Test To Include The Results Of The Supplemental Clinical Data Submitted In The Post-Approval Study (PAS) Report P160045/R015 |
| 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 |