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U.S. Department of Health and Human Services

Product Classification
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Device temporary non-roller type left or right heart support blood pump
Definition Providing temporary partial or full left or right heart circulatory support in addition to other treatments for patient during the declared public health emergency.
Physical State n/a
Technical Method n/a
Target Area n/a
Review Panel Cardiovascular
Product CodeQOC
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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