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 NumberS036 Date Received03/29/2022 Decision Date08/11/2022 Product Code PQP Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-29 |
| Decision Date | 2022-08-11 |
| PMA | P160045 |
| Supplement | S036 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LIFE TECHNOLOGIES CORPORATION 5781 Van Allen Way carlsbad, CA 92008 PMA NumberP160045 Supplement NumberS036 Date Received03/29/2022 Decision Date08/11/2022 Product Code PQP Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Reduce The Number Of Replicates Assessed For Quality Control (QC) Release Testing |
| 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 |
| 10190302006385 | P160045 | 000 |