MyChoice CDx®
FDA premarket approval P190014/S007 · decided 2022-11-14
Approval details
- PMA number
- P190014
- Supplement
- S007
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MyChoice CDx®
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories, Inc.
- Date received
- 2022-10-17
- Decision date
- 2022-11-14
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake City, UT
- 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).
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