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 NumberP200006 Supplement NumberS003 Date Received09/30/2022 Decision Date10/28/2022 Product Code PQP Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-09-30 |
| Decision Date | 2022-10-28 |
| PMA | P200006 |
| Supplement | S003 |
| 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 PMA NumberP200006 Supplement NumberS003 Date Received09/30/2022 Decision Date10/28/2022 Product Code PQP Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement Termination Of The Post-approval Study (PAS) Submitted Under P200006/S001 To Comply With The Clinical Condition Of Approval Outlined In The Approval Order For P200006. The Request For Termination Is Due To The Removal Of The Companion Diagnostic Indication For FoundationOne® Liquid CDx To Identify Patients With Ovarian Cancer Harboring BRCA1 Or BRCA2 Alterations For Treatment With Rucaparib As Approved Through P190032/S007. |
| 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 |