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U.S. Department of Health and Human Services

Product Classification
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Device sensor, pressure, aneurysm, implantable
Regulation Description Implantable Intra-aneurysm Pressure Measurement System.
Definition This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNQH
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.2855
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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