myChoice CDx
FDA premarket approval P190014/S003 · decided 2020-05-08
Approval details
- PMA number
- P190014
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- myChoice CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Myriad Genetic Laboratories, Inc.
- Date received
- 2020-02-11
- Decision date
- 2020-05-08
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake City, UT
- 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)".
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