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PMA P140020S020

Device
BRACAnalysis CDx
Applicant
Myriad Genetic Laboratories
PMA number
P140020
Supplement
S020
Product code
PJG
Decision date
2020-05-19
Generic name
Cancer-related germline gene mutation detection system
Approval order statement
Approval to expand the intended use of BRACAnalysis® CDx to include a companion diagnostic indication for BRCA1/2 mutations in patients with metastatic castration resistant prostate cancer who may benefit from treatment with Lynparza® (olaparib).

Current openFDA PMA Record#

Device
BRACAnalysis CDx
Applicant
Myriad Genetic Laboratories
PMA number
P140020
Supplement
S020
Product code
PJG
Generic name
Cancer-related germline gene mutation detection system
Decision date
2020-05-19
Decision code
APPR
Date received
2019-12-06
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval to expand the intended use of BRACAnalysis® CDx to include a companion diagnostic indication for BRCA1/2 mutations in patients with metastatic castration resistant prostate cancer who may benefit from treatment with Lynparza® (olaparib).