- Device
- FoundationOne CDx
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S032
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2022-05-06
- Decision code
- APPR
- Date received
- 2021-03-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the clinical protocol entitled F1CDx Validation Protocol and Statistical Analysis Plan: NTRK Clinical Efficacy Post Approval Study for larotrectinib