- Device
- FoundationOne Liquid CDx
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P200006
- Supplement
- S001
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2022-02-03
- Decision code
- APPR
- Date received
- 2021-03-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the clinical protocol entitled Statistical Analysis Plan Expanded Validation Study for the Efficacy of Rucaparib in Ovarian Cancer based on F1L CDx.