FDA.reportPublic FDA data

PMA P170019S023

Device
FoundationOne CDx (F1CDx)
Applicant
Foundation Medicine, Inc.
PMA number
P170019
Supplement
S023
Product code
PQP
Decision date
2021-06-30
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement
Approval for Expanding the indications for use to include a CDx indication for detecting ALK rearrangements in non-small cell lung cancer patients who may be candidates for brigatinib treatment.

Current openFDA PMA Record#

Device
FoundationOne CDx (F1CDx)
Applicant
Foundation Medicine, Inc.
PMA number
P170019
Supplement
S023
Product code
PQP
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date
2021-06-30
Decision code
APPR
Date received
2020-12-01
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for Expanding the indications for use to include a CDx indication for detecting ALK rearrangements in non-small cell lung cancer patients who may be candidates for brigatinib treatment.