BRACAnalysis CDx
FDA premarket approval P140020/S020 · decided 2020-05-19
Approval details
- PMA number
- P140020
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- 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
- 2019-12-06
- Decision date
- 2020-05-19
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Approval to expand the intended use of BRACAnalysis® CDx to include a companion diagnostic indication for BRCA1/2 mutations in patients with metastatic castration resistant prostate cancer who may benefit from treatment with Lynparza® (olaparib).
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