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U.S. Department of Health and Human Services

Product Classification
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Device pulse-generator, pacemaker, external
Regulation Description External pacemaker pulse generator.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTE
Submission Type 510(k)
Regulation Number 870.3600
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm275701.htm] 
Third Party Review Not Third Party Eligible
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