BRACAnalysis CDx®
FDA premarket approval P140020/S022 · decided 2022-03-11
Approval details
- PMA number
- P140020
- Supplement
- S022
- 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
- 2021-10-22
- Decision date
- 2022-03-11
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Approval for inclusion of an additional clinical study (OlympiA) data in the clinical section of the labeling.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.