Peripheral Percutaneous Transluminal Angioplasty and Specialty Catheters—Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 85 FR 1812

Summary

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters—Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff.” The FDA is issuing this draft guidance document to provide recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g.,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). This draft guidance is not final nor is it in effect at this time.