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U.S. Department of Health and Human Services

Product Classification

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Device aortic stent
Definition Coarctation of the Aorta
Physical State The stent is metal and is offered in a range of diameters
Technical Method An expandable stent is placed in the aorta to keep the vessel open
Target Area Aorta
Review Panel Cardiovascular
Product CodePNF
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
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