PMA P170019S005
- Device
- FoundationOne CDx Assay
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S005
- Product code
- PQP
- Decision date
- 2019-04-10
- Classification
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Approval for FoundationOne CDx (F1CDx) for reporting of homologous recombination deficiency (HRD) status in ovarian cancer patients.
Current openFDA PMA Record#
- Device
- FoundationOne CDx Assay
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S005
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2019-04-10
- Decision code
- APPR
- Date received
- 2018-10-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for FoundationOne CDx (F1CDx) for reporting of homologous recombination deficiency (HRD) status in ovarian cancer patients.