- Device
- FoundationOne® CDx
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S059
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2026-05-08
- Decision code
- APPR
- Date received
- 2024-09-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a manufacturing site change for the FoundationOne®CDx and FoundationOne®LiquidCDx