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 (F1CDx) |
| 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 NumberS035 Date Received06/09/2022 Decision Date07/08/2022 Product Code PQP Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-06-09 |
| Decision Date | 2022-07-08 |
| PMA | P170019 |
| Supplement | S035 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Foundation Medicine, Inc. 150 Second Street, 1st Floor cambridge, MA 02141 PMA NumberP170019 Supplement NumberS035 Date Received06/09/2022 Decision Date07/08/2022 Product Code PQP Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement The Center For Devices And Radiological Health (CDRH) Of The Food And Drug Administration (FDA) Has Completed Its Review Of Your Premarket Approval Application (PMA) 180-day Supplement, Which Requested Approval To Update The Mock Patient Report. Based Upon The Information Submitted, The PMA Supplement Is Approved. You May Begin Commercial Distribution Of The Device As Modified By Your PMA Supplement In Accordance With The Conditions Described Below. |
| 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 |