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U.S. Department of Health and Human Services

Product Classification

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Device generator, pulsatile flow, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass pulsatile flow generator.
Definition Date pma or notice of completion of pdp is required.A pma or notice of completion of a pdp is required to be filed with the food and drug administration on or before september 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before may 28, 1976, or that has, on or before september 21, 2004, been found to be substantially equivalent to any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before may 28, 1976.Any other cardiopulmonary bypass pulsatile flow generator shall have an approved pma or declared completed pdp in effect before being placed in commercial distribution.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeJOR
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type PMA
Regulation Number 870.4320
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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