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 CDx (FICDx) |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Foundation Medicine, Inc.150 Second Street, 1st Floorcambridge, MA 02141 PMA NumberP170019 Supplement NumberS034 Date Received03/18/2022 Decision Date04/13/2022 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 | 2022-03-18 |
| Decision Date | 2022-04-13 |
| PMA | P170019 |
| Supplement | S034 |
| 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, 1st Floor cambridge, MA 02141 PMA NumberP170019 Supplement NumberS034 Date Received03/18/2022 Decision Date04/13/2022 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 Approval Of The Clinical Protocol Entitled Statistical Analysis Plan For MK-3475 MSI-H FMI F1CDx Post Approval Analysis. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170019 | Original Filing | |
| S038 | 2022-08-29 | Special (immediate Track) |
| S037 | ||
| S036 | ||
| S035 | 2022-06-09 | Normal 180 Day Track No User Fee |
| S034 | 2022-03-18 | Normal 180 Day Track No User Fee |
| S033 | 2021-12-23 | Real-time Process |
| S032 | ||
| S031 | ||
| S030 | 2021-07-01 | Normal 180 Day Track |
| S029 | ||
| S028 | 2021-03-23 | Normal 180 Day Track |
| S027 | ||
| S026 | 2020-12-28 | Normal 180 Day Track |
| S025 | ||
| S024 | ||
| S023 | 2020-12-01 | Normal 180 Day Track |
| S022 | ||
| S021 | 2020-10-29 | Normal 180 Day Track |
| S020 | 2020-07-20 | Real-time Process |
| S019 | 2020-04-27 | Real-time Process |
| S018 | 2020-04-16 | 30-day Notice |
| S017 | ||
| S016 | ||
| S015 | 2019-12-16 | Panel Track |
| S014 | ||
| S013 | 2019-10-31 | Panel Track |
| S012 | 2019-10-21 | Special (immediate Track) |
| S011 | ||
| S010 | ||
| S009 | 2019-07-23 | Special (immediate Track) |
| S008 | 2019-04-09 | Normal 180 Day Track |
| S007 | ||
| S006 | ||
| S005 | 2018-10-12 | Normal 180 Day Track |
| S004 | 2018-09-24 | Normal 180 Day Track |
| S003 | 2018-08-30 | Real-time Process |
| S002 | 2018-08-24 | Real-time Process |
| S001 |