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“Under section 501(c) of the Federal Food, Drug, and Cosmetic Act (the Act), a device is adulterated if its quality falls below that which it purports or is represented to possess,” FDA explains on the list, noting it “has collected and analyzed samples of various medical devices which have not met the quality level that they purported or were represented to possess, in accordance with acceptance criteria in a standard or in a manufacturer's Quality System (QS) Regulation acceptance procedure. Devices which do not meet their own established medical device specifications or the quality level they were represented to meet could result in a potential health risk to the end user.”
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Rontis Corporation S.A. announces that its Swiss subsidiary Rontis AG (Zug, Switzerland) has signed an agreement with Nipro Medical Corporation (Miami, USA), a wholly-owned subsidiary of Nipro Corporation, for the exclusive distribution of the Rontis Cronus™ HP 0.035” PTA Balloon Catheter in the United States.
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