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U.S. Department of Health and Human Services

Product Classification
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Device permanent pacemaker electrode
Regulation Description Cardiovascular permanent or temporary pacemaker electrode.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTB
Submission Type 510(k)
Regulation Number 870.3680
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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