PMA P170019S020
- Device
- FoundationOne CDx
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S020
- Product code
- PQP
- Decision date
- 2020-10-15
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Approval for the deployment of an updated version of the F1CDx analysis pipeline (v.3.4.5).
Current openFDA PMA Record#
- Device
- FoundationOne CDx
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S020
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2020-10-15
- Decision code
- APPR
- Date received
- 2020-07-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the deployment of an updated version of the F1CDx analysis pipeline (v.3.4.5).