BRACAnalysis CDx®
FDA premarket approval P140020/S029 · decided 2024-10-04
Approval details
- PMA number
- P140020
- Supplement
- S029
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRACAnalysis CDx®
- Applicant
- Myriad Genetic Laboratories
- Date received
- 2024-06-04
- Decision date
- 2024-10-04
- Days to decision
- 122 days
- Decision code
- APPR
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Approval of manufacturing site change for BRACAnalysis CDx®
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