PMA P140020S002
- Device
- BRACANALYSIS CDX
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S002
- Product code
- PJG
- Decision date
- 2016-07-26
- Classification
- Cancer-related Germline Gene Mutation Detection System
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- Approval for 1) labeling changes to include results from additional non-clinical studies, and 2) a variant reclassification process.
Current openFDA PMA Record#
- Device
- BRACANALYSIS CDX
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S002
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2016-07-26
- Decision code
- APPR
- Date received
- 2015-07-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for 1) labeling changes to include results from additional non-clinical studies, and 2) a variant reclassification process.