sábado, 30 de junio de 2018

Recently Approved Devices




PD-L1 IHC 22C3 pharmDx - P150013/S009
PD-L1 IHC 22C3 pharmDx is a laboratory test doctors can use to identify the protein programmed cell death ligand 1 (PD-L1) in tumor tissue obtained from patients with lung and gastric cancer. This supplement expands the indications for use for this test to in

AUGMENT® Injectable - P100006/S005

AUGMENT® Injectable is a combination product composed of two device components and one drug component. It is indicated for use as an alternative to using a patient's own tissue (autograft) in arthrodesis (i.e., fusion procedures) of the ankle and/or hindfoot when supplemental graft material is needed.

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