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U.S. Department of Health and Human Services

Product Classification

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Device catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Definition To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.
Physical State Cutting/scoring PTCA catheters are usually comprised of flexible polymers for the catheter body and a compliant polymer for the balloon. The cutting/scoring elements are usually metal.
Technical Method The device functions independently, but is typically placed using a guidewire and guiding catheter. The balloon is inflated by the infusion of liquid through the body of the catheter. Following treatment, the liquid is withdrawn, the balloon is deflated and then withdrawn from the body.
Target Area Coronary arteries.
Review Panel Cardiovascular
Product CodeNWX
Premarket Review Coronary and Peripheral Interventional Devices (DHT2C)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible