PMA P140020S015

Device

BRACAnalysis CDx device

Applicant

Myriad Genetic Laboratories

PMA number

P140020

Supplement

S015

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 an indication for TALZENNA (talazoparib) in breast cancer patients.

Summary

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