JOR

Generator, Pulsatile Flow, Cardiopulmonary Bypass

Product code

JOR

Device name

Generator, Pulsatile Flow, Cardiopulmonary Bypass

Device class

Class 3

21 CFR

21 CFR 870.4320

Medical specialty

Cardiovascular

Marketing pathway

PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).