PMA P170019S030

Device: FoundationOne CDx (F1CDx)
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S030
Product code: PQP
Decision date: 2022-01-19
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 expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic indication for identifying patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, who may benefit from treatment with atezolizumab (Tecentriq) in combination with cobimetinib and vemurafenib.

Current openFDA PMA Record#

Device: FoundationOne CDx (F1CDx)
Applicant: Foundation Medicine, Inc.
PMA number: P170019
Supplement: S030
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2022-01-19
Decision code: APPR
Date received: 2021-07-01
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 expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic indication for identifying patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, who may benefit from treatment with atezolizumab (Tecentriq) in combination with cobimetinib and vemurafenib.