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) |
| 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 NumberS007 Date Received08/29/2022 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 | 2022-08-29 |
| Decision Date | 2022-09-21 |
| PMA | P190032 |
| Supplement | S007 |
| 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 NumberP190032 Supplement NumberS007 Date Received08/29/2022 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 Approved Removal Of The Companion Diagnostic Indication For F1Liquid CDx To Identify Patients With Ovarian Cancer Harboring BRCA1 Or BRCA2 Alterations For Treatment With Rucaparib. |
| 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 |