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Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance document provides draft recommendations, including bench testing and coating characterizations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons). These devices are catheter-based devices intended to treat lesions in the peripheral vasculature. This document provides anatomy-specific testing recommendations and expands on FDA’s current thinking for testing of these devices. FDA is issuing this draft guidance to clarify FDA’s premarket submission recommendations for PTA catheters and specialty catheters and to promote consistency across submissions.