PMA P170019S021

Device: FoundationOne CDx (F1CDx)
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S021
Product code: PQP
Decision date: 2021-05-28
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval to expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic indication for FGFR2 fusion/rearrangements in patients with Cholangiocarcinoma who may benefit from treatment with Truseltiq (infigratinib).

Current openFDA PMA Record#

Device: FoundationOne CDx (F1CDx)
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S021
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2021-05-28
Decision code: APPR
Date received: 2020-10-29
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic indication for FGFR2 fusion/rearrangements in patients with Cholangiocarcinoma who may benefit from treatment with Truseltiq (infigratinib).