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 NumberS033 Date Received12/23/2021 Decision Date03/16/2022 Product Code PQP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2021-12-23 |
| Decision Date | 2022-03-16 |
| PMA | P170019 |
| Supplement | S033 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| 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 NumberS033 Date Received12/23/2021 Decision Date03/16/2022 Product Code PQP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement for FoundationOne CDx (FICDx) Label Expansion To Obtain Companion Diagnostic Group Labeling Claim For Non-small Cell Lung Cancer Patients Harboring EGFR Exon 19 Deletions Or EGFR Exon 21 L858R Mutations For Treatment With Any One Of The FDA-approved EGFR Tyrosine Kinase Inhibitors (TKI) . |
| 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 |