BRACAnalysis CDx device
FDA premarket approval P140020/S015 · decided 2018-10-16
Approval details
- PMA number
- P140020
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BRACAnalysis CDx device
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories
- Date received
- 2018-04-09
- Decision date
- 2018-10-16
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Approval for extending the label claim of the BRACAnalysis CDx to include an indication for TALZENNA (talazoparib) in breast cancer patients.
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