BRACAnalysis CDx
FDA premarket approval P140020/S027 · decided 2023-04-26
Approval details
- PMA number
- P140020
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BRACAnalysis CDx
- Applicant
- Myriad Genetic Laboratories
- Date received
- 2023-01-27
- Decision date
- 2023-04-26
- Days to decision
- 89 days
- Decision code
- APPR
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Approval for the change of Zejula® (niraparib) indication from a complementary diagnostic to a companion diagnostic to aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA1 and BRCA2 mutations, who are or may become eligible for maintenance treatment with Zejula® (niraparib).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.