- Device
- FoundationOne CDx (F1CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S019
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2020-07-24
- Decision code
- APPR
- Date received
- 2020-04-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of software infrastructure modifications for FoundationOne CDx (F1CDx), including modifications involving migrating the analysis pipeline and associated software to the Amazon Web Services (AWS) cloud.