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 |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Foundation Medicine, Inc.150 Second Streetcambridge, MA 02141 PMA NumberP200006 Supplement NumberS002 Date Received08/22/2022 Decision Date09/21/2022 Product Code PQP Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-08-22 |
| Decision Date | 2022-09-21 |
| PMA | P200006 |
| Supplement | S002 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Special (immediate 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 PMA NumberP200006 Supplement NumberS002 Date Received08/22/2022 Decision Date09/21/2022 Product Code PQP Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For The Formatting And Updates To The Specimen Instructions Document, The Technical Labeling, And The Mock Patient Reports For FoundationOne® Liquid CDx |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200006 | Original Filing | |
| S003 | 2022-09-30 | Normal 180 Day Track No User Fee |
| S002 | 2022-08-22 | Special (immediate Track) |
| S001 | 2021-03-23 | Normal 180 Day Track No User Fee |