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U.S. Department of Health and Human Services

Product Classification
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Device tricuspid valve repair device, percutaneously delivered
Definition These devices are intended to repair heart valves by methods other than that used by the classified device (annuloplasty rings). They may be placed using non-traditional techniques or other novel methods for decreasing valvular regurgitation.
Physical State These devices typically comprise an implant, a delivery system, and other components for transcatheter delivery of the implant.
Technical Method The implant used to repair the tricuspid valve is delivered percutaneously via a catheter.
Target Area Tricuspid valve
Review Panel Cardiovascular
Product CodeNPS
Premarket Review Office of 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
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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