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This article was originally published in Clinica
Guidant subsidiary Devices for Vascular Intervention (DVI) has received US FDA approval of a PMA supplement for its AtheroCath-GTO atherectomy catheter, allowing it to resume production and shipment of the device. DVI stopped shipment of the AtheroCath last month pending review by the FDA of modifications to the catheter and the device has not been sold in the US for some 30 days.
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