FDA.reportPublic FDA data

PMA P190014S003

Device
myChoice CDx
Applicant
Myriad Genetic Laboratories, Inc.
PMA number
P190014
Supplement
S003
Product code
PQP
Decision date
2020-05-08
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement
Approval for Myriad myChoice® CDx to include a companion diagnostic indication for homologous recombination deficiency (HRD) in ovarian cancer patients who may benefit from maintenance treatment with Lynparza® (olaparib)".

Current openFDA PMA Record#

Device
myChoice CDx
Applicant
Myriad Genetic Laboratories, Inc.
PMA number
P190014
Supplement
S003
Product code
PQP
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date
2020-05-08
Decision code
APPR
Date received
2020-02-11
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for Myriad myChoice® CDx to include a companion diagnostic indication for homologous recombination deficiency (HRD) in ovarian cancer patients who may benefit from maintenance treatment with Lynparza® (olaparib)".