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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
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

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1

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