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.
Approval to expand the intended use of foundationone cdx (f1cdx) to include a companion diagnostic indication for fgfr2 fusion/rearrangements in patients with cholangiocarcinoma who may benefit from treatment with truseltiq™ (infigratinib).
| Device | FoundationOne CDx (F1CDx) |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Foundation Medicine, Inc. |
| Date Received | 2020-10-29 |
| Decision Date | 2021-05-28 |
| PMA | P170019 |
| Supplement | S021 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Foundation Medicine, Inc. 150 Second Street, 1st Floor cambridge, MA 02141 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170019 | Original Filing | |
| S038 | 2022-08-29 | Special (immediate Track) |
| S037 | ||
| S036 | ||
| S035 | 2022-06-09 | Normal 180 Day Track No User Fee |
| S034 | 2022-03-18 | Normal 180 Day Track No User Fee |
| S033 | 2021-12-23 | Real-time Process |
| S032 | ||
| S031 | ||
| S030 | 2021-07-01 | Normal 180 Day Track |
| S029 | ||
| S028 | 2021-03-23 | Normal 180 Day Track |
| S027 | ||
| S026 | 2020-12-28 | Normal 180 Day Track |
| S025 | ||
| S024 | ||
| S023 | 2020-12-01 | Normal 180 Day Track |
| S022 | ||
| S021 | 2020-10-29 | Normal 180 Day Track |
| S020 | 2020-07-20 | Real-time Process |
| S019 | 2020-04-27 | Real-time Process |
| S018 | 2020-04-16 | 30-day Notice |
| S017 | ||
| S016 | ||
| S015 | 2019-12-16 | Panel Track |
| S014 | ||
| S013 | 2019-10-31 | Panel Track |
| S012 | 2019-10-21 | Special (immediate Track) |
| S011 | ||
| S010 | ||
| S009 | 2019-07-23 | Special (immediate Track) |
| S008 | 2019-04-09 | Normal 180 Day Track |
| S007 | ||
| S006 | ||
| S005 | 2018-10-12 | Normal 180 Day Track |
| S004 | 2018-09-24 | Normal 180 Day Track |
| S003 | 2018-08-30 | Real-time Process |
| S002 | 2018-08-24 | Real-time Process |
| S001 |