PMA P140020S026
- Device
- BRACAnalysis CDx®
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S026
- Product code
- PJG
- Decision date
- 2023-01-27
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- Extension of lab space.
Current openFDA PMA Record#
- Device
- BRACAnalysis CDx®
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S026
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2023-01-27
- Decision code
- OK30
- Date received
- 2023-01-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extension of lab space.