FoundationOne CDx
FDA premarket approval P170019/S058 · decided 2024-10-25
Approval details
- PMA number
- P170019
- Supplement
- S058
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- FoundationOne CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2024-08-26
- Decision date
- 2024-10-25
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for updates to labeling including updates to the Technical Information document for F1CDx.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.