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 of the clinical protocol entitled “statistical analysis plan expanded validation study for the efficacy of rucaparib in ovarian cancer based on f1l cdx”. Pas protocol was submitted to comply with the conditions of approval outlined in the approval order for p200006.
| Device | FoundationOne Liquid CDx |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Foundation Medicine, Inc. |
| Date Received | 2021-03-23 |
| Decision Date | 2022-02-03 |
| PMA | P200006 |
| Supplement | S001 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Foundation Medicine, Inc. 150 Second Street cambridge, MA 02141 |
| 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 |