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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pediatric ventricular assist device
Regulation Description Ventricular bypass (assist) device.
Definition A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.
Product CodePCK
Regulation Number 870.3545
Device Class Humanitarian Device Exemption

Device Problems
Air leak 1
Break 1
Leak 1
Device operates differently than expected 1
Total Device Problems 4

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