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U.S. Department of Health and Human Services

Product Classification
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Device heart-valve, polymeric
Definition This device is a permanent implant intended to replace a heart valve.
Physical State The device is comprised of a support structure (e.g., frame) and valve leaflets. The valve leaflets are constructed with polymeric materials.
Technical Method The heart valve device is placed during open heart surgery in the position of a native heart valve to replace its function.
Target Area Heart valves, including aortic valve, mitral valve, pulmonary valve, and tricuspid valve
Review Panel Cardiovascular
Product CodeSJL
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
Third Party Review Not Third Party Eligible
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