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U.S. Department of Health and Human Services

Product Classification
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Device pulmonary stent
Definition A pulmonary stent is a metal scaffold placed via a delivery catheter into the pulmonary artery to maintain the lumen.
Physical State The stent is metal and is offered in a range of diameters
Technical Method An expandable stent is placed in the pulmonary artery to keep the vessel open.
Target Area Pulmonary artery
Review Panel Cardiovascular
Product CodeQWC
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
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
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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