PMA P200016

Device: FoundationOne Liquid CDx
Applicant: Foundation Medicine, Inc.
PMA number: P200016
Supplement: S001
Product code: PQP
Decision date: 2023-03-08
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval for Waiver of Condition of Approval (CoA) for Contrived Sample Functional Characterization (CSFC) study for F1 Liquid CDx.

Current openFDA PMA Record#

Device: FoundationOne Liquid CDx
Applicant: Foundation Medicine, Inc.
PMA number: P200016
Supplement: S002
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2023-03-08
Decision code: APPR
Date received: 2022-09-09
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for Waiver of Condition of Approval (CoA) for Contrived Sample Functional Characterization (CSFC) study for F1 Liquid CDx.