PMA P200016S001

Device: FoundationOne®Liquid CDx
Applicant: Foundation Medicine, Inc.
PMA number: P200016
Supplement: S001
Product code: PQP
Decision date: 2022-09-21
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval for the formatting and updates to the Specimen Instructions document, the technical labeling, and the mock patient reports for FoundationOne® Liquid CDx.

Current openFDA PMA Record#

Device: FoundationOne®Liquid CDx
Applicant: Foundation Medicine, Inc.
PMA number: P200016
Supplement: S001
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2022-09-21
Decision code: APPR
Date received: 2022-08-22
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the formatting and updates to the Specimen Instructions document, the technical labeling, and the mock patient reports for FoundationOne® Liquid CDx.