Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

Issue Date: April 14, 2023
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Cardiovascular , Labeling
Status: Final

Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

This guidance document provides the FDA’s recommendations on non-clinical testing, animal studies and clinical studies (when warranted), and labeling to support premarket submissions for peripheral percutaneous transluminal angioplasty (PTA) balloon and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons). This guidance applies only to PTA catheters that are not combination products (i.e., drug-coated PTA catheters). The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral PTA balloon and specialty catheter submissions.

Download the Guidance Document