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.