BRACAnalysis CDx®
FDA premarket approval P140020/S025 · decided 2022-11-16
Approval details
- PMA number
- P140020
- Supplement
- S025
- Supplement type
- Special (Immediate 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
- 2022-10-18
- Decision date
- 2022-11-16
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Approval for the removal of the companion diagnostic indication for BRACAnalysis CDx to identify patients with ovarian, fallopian tube, or primary peritoneal cancer with homologous recombination deficiency (HRD) positive status for treatment with Lynparza® (olaparib) and Rubraca® (rucaparib).
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