PMA P140020
- Device
- BRACAnalysis CDx®
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S026
- Product code
- PJG
- Decision date
- 2024-10-04
- Generic name
- Cancer-related Germline Gene Mutation Detection System
- Approval order statement
- Approval of manufacturing site change for BRACAnalysis CDx®
Current openFDA PMA Record#
- Device
- BRACAnalysis CDx®
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S029
- Decision date
- 2024-10-04
- Decision code
- APPR
- Date received
- 2024-06-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of manufacturing site change for BRACAnalysis CDx®