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U.S. Department of Health and Human Services

Product Classification

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Device shockwave intravascular lithotripsy system
Definition Dilatation of coronary arteries prior to stenting
Physical State Catheter, connector cables, generator.
Technical Method Percutaneous, intravascular delivery of the device to lesions in the coronary arteries
Target Area Coronary arteries
Review Panel Cardiovascular
Product CodeQMG
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
Third Party Review Not Third Party Eligible