PMA P140020S006
- Device
- BRACANALYSIS CDX
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S006
- Product code
- PJG
- Decision date
- 2016-06-17
- Classification
- Cancer-related Germline Gene Mutation Detection System
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- Approval to remove the Variant Viewer application tool from the BRACAnalysis CDx device.
Current openFDA PMA Record#
- Device
- BRACANALYSIS CDX
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S006
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2016-06-17
- Decision code
- APPR
- Date received
- 2016-03-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to remove the Variant Viewer application tool from the BRACAnalysis CDx device.