Generator, Pulsatile Flow, Cardiopulmonary Bypass
The Generator, Pulsatile Flow, Cardiopulmonary Bypass is a high-risk cardiovascular device used during open-heart surgery to generate pulsatile blood flow within the cardiopulmonary bypass circuit, mimicking the natural pulsatile output of the heart and supporting organ perfusion during cardiac procedures. As described in the regulatory definition, a PMA or notice of completion of a Product Development Protocol (PDP) is required; any device in commercial distribution before May 28, 1976, or found substantially equivalent to such devices required a filed PMA or completed PDP by September 21, 2004, and any other device must have an approved PMA or declared completed PDP before commercial distribution. This device is FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) demonstrating safety and effectiveness. It carries product code JOR and is regulated under 21 CFR 870.4320, within the Cardiovascular medical specialty.
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Basic Information
- Product Code
- JOR
- Device Class
- FDA class 3
- Regulation Number
- 870.4320
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
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.