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U.S. FDA Medical Device External Pacemaker Pulse Generator Requirements: External Pacemaker Pulse Generator

FDA Medical Device Definition: An external pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing sytem until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables

Registrar Corp assists External Pacemaker Pulse Generator companies with:

  • FDA External Pacemaker Pulse Generator Establishment Registration
  • FDA External Pacemaker Pulse Generator Listing
  • FDA External Pacemaker Pulse Generator Label Requirements and Exceptions
  • FDA External Pacemaker Pulse Generator Import Information
  • FDA External Pacemaker Pulse Generator Detentions (External Pacemaker Pulse Generator Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - External Pacemaker Pulse Generator Manufacturers (External Pacemaker Pulse Generator Suppliers)
       - External Pacemaker Pulse Generator Distributors
       - External Pacemaker Pulse Generator Processors
       - External Pacemaker Pulse Generator Repackers
       - External Pacemaker Pulse Generator Relabelers
       - External Pacemaker Pulse Generator Exporters
       - External Pacemaker Pulse Generator Importers
For more information about External Pacemaker Pulse Generator Medical Devices, simply click below:




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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