• 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 pacemaker lead adaptor
Regulation Description Pacemaker lead adaptor.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTD
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type 510(k)
Regulation Number 870.3620
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
-
-