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U.S. Department of Health and Human Services

Product Classification

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Device pulmonic replacement heart valve
Regulation Description Replacement heart valve.
Definition For open surgical replacement of malfunctioning pulmonic heart valve.
Physical State Animal tissue valve that has three leaflets and a ring of either tissue or fabric (called the sewing ring) that accepts sutures for sewing into the patient's annulus.
Technical Method after being sewn into annulus, the leaflets open and close at appropriate periods in the heart beat cycle to control the flow of blood.
Target Area Sutured into the heart in the location where the native pulmonic valve used to reside (pulmonic valve annulus).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePAL
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type HDE - Humanitarian Device Exemption
Regulation Number 870.3925
Device Class HDE
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