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April 1, 2012
FDA Clears Natec's Ebony PTA Rx Catheter for Below-the-Knee Treatment
March 30, 2012—Natec Medical, Ltd. (Reduit, Mauritius) announced that it has receive 510(k) clearance for the Ebony PTA Rx, a .014-inch percutaneous transluminal angioplasty catheter designed to be able to reach and treat remote infrapopliteal lesions.
The company will now begin marketing the device in the United States. Natec has also received regulatory approval for marketing the device in Europe and other countries that recognize the CE Mark. Natec's Ebony catheter is available in diameters of 2 to 8 mm and lengths of 10 to 60 mm. Extended sizes up to 200 mm will be offered in the near future, stated the company.
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