- Device
- myChoice CDx
- Applicant
- Myriad Genetic Laboratories, Inc.
- PMA number
- P190014
- Supplement
- S004
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2021-01-27
- Decision code
- APPR
- Date received
- 2020-07-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for Myriad myChoice® CDx to expand labeling based on SOLO1 study for the treatment of the patients with BRCA mutated advanced ovarian cancer with LYNPARZA (olaparib).