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U.S. Department of Health and Human Services

Product Classification

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Device ventricular bypass (assist) device
Regulation Description Ventricular bypass (assist) device.
Definition A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours.The device is either totally or partially implanted in the body.
Physical State A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for < 6 hours. The device is either totally or partially implanted in the body.
Technical Method A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for < 6 hours. The device is either totally or partially implanted in the body.
Target Area A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for < 6 hours. The device is either totally or partially implanted in the body.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOKR
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type PMA
Regulation Number 870.3545
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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