PMA P140020S007
- Device
- BRACANALYSIS CDx
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S007
- 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 DNA extraction system from serialization, and to remove non-critical instruments from the specified device components.
Current openFDA PMA Record#
- Device
- BRACANALYSIS CDx
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S007
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2016-06-17
- Decision code
- APPR
- Date received
- 2016-06-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to remove the DNA extraction system from serialization, and to remove non-critical instruments from the specified device components.