PMA P140020S022
- Device
- BRACAnalysis CDx®
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S022
- Product code
- PJG
- Decision date
- 2022-03-11
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- Approval for inclusion of an additional clinical study (OlympiA) data in the clinical section of the labeling.
Current openFDA PMA Record#
- Device
- BRACAnalysis CDx®
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S022
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2022-03-11
- Decision code
- APPR
- Date received
- 2021-10-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for inclusion of an additional clinical study (OlympiA) data in the clinical section of the labeling.