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U.S. Department of Health and Human Services

Product Classification
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Device temporary non-roller type right heart support blood pump
Regulation Description Nonroller-type blood pump.
Definition Providing temporary partial or full right heart circulatory support.
Physical State Rotor or axial type pump manufactured of various materials. Single use, disposable.
Technical Method Assists with partial or full right heart blood circulation either during an adjunctive procedure where the patient requires hemodynamic stability, or a temporary use of the device to unload the right heart to give it time to recover from an acute condition.
Target Area Heart.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePYX
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type PMA
Regulation Number 870.4360
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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