PMA P170019S069

Device: FoundationOne CDx
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S069
Product code: PQP
Decision date: 2026-09-16
Classification: Pathology
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval to update the F1CDx labeling to include the results of the supplemental clinical data submitted in the Post-Approval Study (PAS) Report

Current openFDA PMA Record#

Device: FoundationOne CDx
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S069
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-09-16
Decision code: APPR
Date received: 2026-03-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval to update the F1CDx labeling to include the results of the supplemental clinical data submitted in the Post-Approval Study (PAS) Report