FDA.reportPublic FDA data

PMA P170019S025

Device
FoundationOne CDx
Applicant
Foundation Medicine, Inc.
Product code
PQP
Decision date
2021-11-10
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement
Approval for the FoundationOne CDx. The device is intended use is expanded to grant companion diagnostic group labeling claims for melanoma patients harboring BRAF V600E alterations for BRAF inhibitor monotherapy group claim and for BRAF V600E or V600K alterations for BRAF/MEK inhibitor combination group claim.

Current openFDA PMA Record#

Device
FoundationOne CDx
Applicant
Foundation Medicine, Inc.
PMA number
P170019
Supplement
S025
Product code
PQP
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date
2021-11-10
Decision code
APPR
Date received
2020-12-28
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for the FoundationOne CDx. The device is intended use is expanded to grant companion diagnostic group labeling claims for melanoma patients harboring BRAF V600E alterations for BRAF inhibitor monotherapy group claim and for BRAF V600E or V600K alterations for BRAF/MEK inhibitor combination group claim.