Cardiac Pacemakers, Inc.
United StatesFDA applicant, unverified
- Devices
- 76
What Cardiac Pacemakers, Inc. makes
Cardiac Pacemakers, Inc. manufactures cardiac pacing devices, including bipolar pulse generators (programmable and demand), programmer systems for device programming and electrogram recording, and specialized tools like universal cutters and stylets. Their portfolio also includes chip revisions for existing pacemaker models and microthin bipolar pulse generators designed for precise cardiac stimulation.
The company’s devices are classified under FDA categories Class I, Class II, and Class III, with regulatory submissions supported via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry, reflecting their authorised status for commercial distribution in the US.
Catalogue
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