PMA P190014S007

Device: MyChoice CDx®
Applicant: Myriad Genetic Laboratories, Inc.
PMA number: P190014
Supplement: S007
Product code: PJG
Decision date: 2022-11-14
Generic name: Cancer-related germline gene mutation detection system
Approval order statement: Approved removal of the companion diagnostic indication for MyChoice® CDx to identify patients with ovarian, fallopian tube, or primary peritoneal cancer with homologous recombination deficiency (HRD) positive status for treatment with Zejula (niraparib).

Current openFDA PMA Record#

Device: MyChoice CDx®
Applicant: Myriad Genetic Laboratories, Inc.
PMA number: P190014
Supplement: S007
Product code: PJG
Generic name: Cancer-related germline gene mutation detection system
Decision date: 2022-11-14
Decision code: APPR
Date received: 2022-10-17
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approved removal of the companion diagnostic indication for MyChoice® CDx to identify patients with ovarian, fallopian tube, or primary peritoneal cancer with homologous recombination deficiency (HRD) positive status for treatment with Zejula (niraparib).