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The Mammotome® elite Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. - The Mammotome® elite Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. - The Mammotome® elite Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The Mammotome® elite Biopsy System is composed of a reusable Holster and a single-patient use, sterile Probe that may be used with ultrasound imaging guidance to excise and collect diagnostic samples with a single insertion of the Probe. The components of the system are designed to operate safely when used together for diagnostic sampling of tissue during a biopsy procedure. The Holster is a self-contained, handheld, reusable electromechanical vacuum-assisted biopsy device that consists of a rechargeable lithium-polymer battery and includes AC power cord and accessories. The Probe consists of an outer trocar shaft, a telescoping inner hollow coaxial cutter and an integrated coaxial cannula. The Probe incorporates a distal needle aperture and a proximal specimen collection cup with a tissue sample basket and specimen collection cap. The Holster contains one alignment tab that inserts into the holster notch located on the body of the Probe body also contains two locking tabs to secure the Probe into the Holster creates vacuum inside the device to assist in pulling tissue into the aperture while the sharpened inner cutter rotates at high speeds and extends across the aperture to acquire targeted tissue. The tissue sample is transported by vacuum to the specimen collection cup. The integrated coaxial cannula may be detached after the biopsy and remain in the breast to the biopsy site when placing a biopsy site identifier.