myChoice CDx
FDA premarket approval P190014/S004 · decided 2021-01-27
Approval details
- PMA number
- P190014
- Supplement
- S004
- Supplement type
- Normal 180 Day 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
- 2020-07-28
- Decision date
- 2021-01-27
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake City, UT
- 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).
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