MyChoice® CDx
FDA premarket approval P190014/S010 · decided 2024-10-04
Approval details
- PMA number
- P190014
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MyChoice® CDx
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories, Inc.
- Date received
- 2024-06-14
- Decision date
- 2024-10-04
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval of manufacturing site change for MyChoice® CDx
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