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 NumberP190032 Supplement NumberS003 Date Received10/28/2021 Decision Date05/25/2022 Product Code PQP Advisory Committee Pathology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2021-10-28 |
| Decision Date | 2022-05-25 |
| PMA | P190032 |
| Supplement | S003 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Foundation Medicine Inc. 150 Second Street cambridge, MA 02141 PMA NumberP190032 Supplement NumberS003 Date Received10/28/2021 Decision Date05/25/2022 Product Code PQP Advisory Committee Pathology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Updating Of Dual Index Barcode (DIB) Primer From DIBv1 To DIBv2 For F1L CDx Device. |
| 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 |