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 include a companion diagnostic indication for detection of met single nucleotide variants (snvs) and indels that lead to met exon 14 skipping in non-small cell lung cancer patients who may benefit from treatment with tabrecta (capmatinib)
| Device | FoundationOne Liquid CDx (F1 Liquid CDx) |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Foundation Medicine Inc. |
| Date Received | 2020-08-28 |
| Decision Date | 2021-07-15 |
| PMA | P190032 |
| Supplement | S001 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Foundation Medicine Inc. 150 Second Street cambridge, MA 02141 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190032 | Original Filing | |
| S008 | 2022-09-26 | Real-time Process |
| S007 | 2022-08-29 | Special (immediate Track) |
| S006 | 2022-08-22 | Special (immediate Track) |
| S005 | ||
| S004 | ||
| S003 | 2021-10-28 | Normal 180 Day Track |
| S002 | ||
| S001 | 2020-08-28 | Panel Track |