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U.S. Department of Health and Human Services

Product Classification
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Device agent, occluding, vascular, permanent
Definition The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels.
Physical State The device consists of a polymerizing glue and delivery system for injection into the vasculature.
Technical Method The material polymerizes in the vessel to permanently coapt or occlude the vessel.
Target Area Peripheral vasculature
Review Panel Cardiovascular
Product CodePJQ
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		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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