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U.S. Department of Health and Human Services

Product Classification

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Device absorbable coronary drug-eluting stent
Definition An absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Physical State Mesh tube in various lengths and diameters
Technical Method Provides mechanical support to the treated artery and a drug agent to prevent restenosis of the treated artery, and then gradually dissolves and is absorbed by the body.
Target Area Coronary arteries
Review Panel Cardiovascular
Product CodePNY
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? Yes
Life-Sustain/Support Device? Yes
Recognized Consensus Standard
Third Party Review Not Third Party Eligible