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U.S. Department of Health and Human Services

Product Classification
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Device temporary non-roller type left heart support blood pump
Definition A blood pump that provides temporary full or partial left heart support
Physical State Rotor or axial type pump manufactured of various materials. Single use, disposable.
Technical Method pumps part or all of the patient's blood circulation either during an adjunctive procedure where the patient requires hemodynamic stability, or a temporary use of the device to unload the heart to give it time to recover from an acute condition.
Target Area Heart
Review Panel Cardiovascular
Product CodeOZD
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type PMA
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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