PMA P140020S014
- Device
- BRACAnalysis CDx
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S014
- Product code
- PJG
- Decision date
- 2019-03-06
- Classification
- Cancer-related Germline Gene Mutation Detection System
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- Approval for changes to the device labeling related to software/database and test report mockups
Current openFDA PMA Record#
- Device
- BRACAnalysis CDx
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S014
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2019-03-06
- Decision code
- APPR
- Date received
- 2018-03-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the device labeling related to software/database and test report mockups