PMA P140020S019
- Device
- BRACAnalysis CDx
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S019
- Product code
- PJG
- Decision date
- 2019-12-27
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- Approval for expansion of the indications for use as a companion diagnostic for LYNPARZA (olaparib) inpancreatic cancer patients
Current openFDA PMA Record#
- Device
- BRACAnalysis CDx
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S019
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2019-12-27
- Decision code
- APPR
- Date received
- 2019-07-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for expansion of the indications for use as a companion diagnostic for LYNPARZA (olaparib) inpancreatic cancer patients