FDA.reportPublic FDA data

PMA P140020S016

Device
BRACAnalysis CDx
Applicant
Myriad Genetic Laboratories
PMA number
P140020
Supplement
S016
Product code
PJG
Decision date
2018-10-16
Classification
Cancer-related Germline Gene Mutation Detection System
Generic name
Cancer-related germline gene mutation detection system
Approval order statement
Approval for extending the label claim of the BRACAnalysis CDx® to include treatment and maintenance indications for Rubraca® (rucaparib) in ovarian cancer patients.

Current openFDA PMA Record#

Device
BRACAnalysis CDx
Applicant
Myriad Genetic Laboratories
PMA number
P140020
Supplement
S016
Product code
PJG
Generic name
Cancer-related germline gene mutation detection system
Decision date
2018-10-16
Decision code
APPR
Date received
2018-06-29
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for extending the label claim of the BRACAnalysis CDx® to include treatment and maintenance indications for Rubraca® (rucaparib) in ovarian cancer patients.