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Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions. These medical devices are catheter-based devices intended to treat lesions (narrowed blood vessels) in the peripheral vascular system (blood vessels in the arms and legs).
Facts about the final guidance
This final guidance provides premarket submission recommendations for continuous flush catheters, percutaneous catheters, peripheral transluminal angioplasty catheters, and percutaneous cutting/scoring catheters including:
- Non-clinical performance testing, including bench testing and animal testing.
- Device labeling information and device modifications.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
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