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 | Praxis Extended RAS Panel |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Illumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS022 Date Received06/13/2022 Decision Date07/05/2022 Product Code PQP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-13 |
| Decision Date | 2022-07-05 |
| PMA | P160038 |
| Supplement | S022 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Illumina, Inc. 5200 Illumina Way san Diego, CA 92122 PMA NumberP160038 Supplement NumberS022 Date Received06/13/2022 Decision Date07/05/2022 Product Code PQP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement device Shipping/storage Changes And Increased Lot Sizes For A Buffer Component Of The Praxis Extended RAS Panel |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160038 | Original Filing | |
| S024 | 2022-12-22 | 30-day Notice |
| S023 | 2022-08-18 | 30-day Notice |
| S022 | 2022-06-13 | 30-day Notice |
| S021 | 2022-02-28 | 30-day Notice |
| S020 | 2021-04-12 | 30-day Notice |
| S019 | ||
| S018 | 2020-11-09 | 30-day Notice |
| S017 | 2020-08-04 | 30-day Notice |
| S016 | 2020-04-06 | 30-day Notice |
| S015 | 2020-01-16 | 30-day Notice |
| S014 | 2019-10-29 | 30-day Notice |
| S013 | 2019-07-31 | 30-day Notice |
| S012 | 2019-04-24 | 30-day Notice |
| S011 | ||
| S010 | 2019-03-06 | 30-day Notice |
| S009 | 2019-02-15 | 30-day Notice |
| S008 | 2019-02-15 | 30-day Notice |
| S007 | 2018-12-10 | 30-day Notice |
| S006 | 2018-08-24 | 30-day Notice |
| S005 | 2018-08-06 | 30-day Notice |
| S004 | 2018-06-01 | 30-day Notice |
| S003 | 2018-04-04 | 30-day Notice |
| S002 | 2018-03-05 | Special (immediate Track) |
| S001 | 2018-03-01 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00816270020088 | P160038 | 000 |