PMA P170019S035
- Device
- FoundationOne CDx (F1CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S035
- Product code
- PQP
- Decision date
- 2022-07-08
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Approval to update the mock patient report.
Current openFDA PMA Record#
- Device
- FoundationOne CDx (F1CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S035
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2022-07-08
- Decision code
- APPR
- Date received
- 2022-06-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to update the mock patient report.