BRACANALYSIS CDX
FDA premarket approval P140020/S002 · decided 2016-07-26
Approval details
- PMA number
- P140020
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BRACANALYSIS CDX
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories
- Date received
- 2015-07-22
- Decision date
- 2016-07-26
- Days to decision
- 370 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Approval for 1) labeling changes to include results from additional non-clinical studies, and 2) a variant reclassification process.
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