FoundationOne CDx (F1CDx)
FDA premarket approval P170019/S040 · decided 2023-07-20
Approval details
- PMA number
- P170019
- Supplement
- S040
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne CDx (F1CDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2023-01-30
- Decision date
- 2023-07-20
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for updates to the F1CDx labeling, including updates to the Technical Information document and patient mock reports for F1CDx.
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