Pulse Generators, Models 5983, 5989

These pulse generators, Models 5983 and 5989, are explicitly described as reusable medical devices. They are intended for implantation and are not meant to be discarded after a single use, though proper maintenance and sterilization (if applicable) would be required for reuse, as per standard medical device reprocessing protocols for implantable devices.

These pulse generators are designed for patients requiring cardiac pacing support, meaning they regulate heart rhythm by delivering electrical impulses to the heart. They are classified under the FDA’s nomenclature for Implantable Pacemaker Pulse-Generators, making them suitable for individuals with conditions like bradycardia or other cardiac conduction disorders where artificial pacing is necessary.

These pulse generators (Models 5983 and 5989) are regulated under FDA 510(k) clearance with the decision labeled as ‘Substantially Equivalent’ (SESE). This means the FDA determined they have the same intended use, technological characteristics, and performance as a legally marketed device already on the market, ensuring they meet safety and effectiveness standards without requiring a full approval process.

The provided data does not specify any particular storage conditions (e.g., temperature, humidity, or handling requirements) for these pulse generators. As reusable implantable devices, they should be stored in accordance with general medical device reprocessing guidelines to maintain functionality and sterility before reuse, though no explicit sterility information is included in the available documentation.

These devices fall under the FDA product code DXY and are governed by regulation 870.3610. Their review was completed in 1979 under the Cardiovascular (CV) Advisory Committee, with a Traditional 510(k) clearance process. The decision was classified as Substantially Equivalent (SESE), and the applicant was Medtronic Vascular, based in Walker, Michigan.