• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device materials, repair or replacement, pacemaker
Regulation Description Pacemaker repair or replacement material.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKFJ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
Submission Type PMA
Regulation Number 870.3710
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-