FDA.reportPublic FDA data

PMA P170019S015

Device
FoundationOne CDx
Applicant
Foundation Medicine, Inc.
PMA number
P170019
Supplement
S015
Product code
PQP
Decision date
2020-05-19
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 to include a companion diagnostic indication for homologous recombination repair (HHR) gene alterations in patients with metastatic castration resistant prostate cancer who may benefit from treatment with Lynparza®(olaparib).

Current openFDA PMA Record#

Device
FoundationOne CDx
Applicant
Foundation Medicine, Inc.
PMA number
P170019
Supplement
S015
Product code
PQP
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date
2020-05-19
Decision code
APPR
Date received
2019-12-16
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval to expand the intended use of FoundationOne®CDx to include a companion diagnostic indication for homologous recombination repair (HHR) gene alterations in patients with metastatic castration resistant prostate cancer who may benefit from treatment with Lynparza®(olaparib).