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 | FoundationOne Liquid CDx (F1 Liquid CDx) - based Clinical Trial Assay |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Foundation Medicine Inc.150 Second Streetcambridge, MA 02141 PMA NumberP190032 Supplement NumberS008 Date Received09/26/2022 Decision Date12/19/2022 Product Code PQP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-09-26 |
| Decision Date | 2022-12-19 |
| PMA | P190032 |
| Supplement | S008 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| 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 PMA NumberP190032 Supplement NumberS008 Date Received09/26/2022 Decision Date12/19/2022 Product Code PQP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For FoundationOne® Liquid CDx (FILCDx) Label Expansion To Obtain Companion Diagnostic Group Labeling Claim For Patients With Non-small Cell Lung Cancer Harboring EGFR Exon 19 Deletions Or EGFR Exon 21 L858R Mutations For Treatment With Any One Of The FDA-approved EGFR Tyrosine Kinase Inhibitors (TKI). |
| 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 |