BRACAnalysis CDx
FDA premarket approval P140020/S014 · decided 2019-03-06
Approval details
- PMA number
- P140020
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRACAnalysis CDx
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories
- Date received
- 2018-03-22
- Decision date
- 2019-03-06
- Days to decision
- 349 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Approval for changes to the device labeling related to software/database and test report mockups
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