PMA P170019S065
- Device
- FoundationOne CDx
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S065
- Product code
- PQP
- Decision date
- 2026-05-27
- Classification
- Pathology
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Approval for updates to the Technical Information document for F1CDx.
Current openFDA PMA Record#
- Device
- FoundationOne CDx
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S065
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2026-05-27
- Decision code
- APPR
- Date received
- 2025-02-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the Technical Information document for F1CDx.