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U.S. Department of Health and Human Services

Product Classification

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Device scaffold, dissection repair
Definition For the repair of dissections following percutaneous transluminal angioplasty in the lower extremity arteries
Physical State Metal or polymer scaffold and catheter delivery system
Technical Method A metal or polymer scaffold place via a delivery catheter into the lower extremity arteries
Target Area Lower extremity arteries
Review Panel Cardiovascular
Product CodeQCT
Premarket Review Cardiovascular Devices (OHT2)
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
Third Party Review Not Third Party Eligible