• 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/icd/crt non-implanted components
Definition Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
Physical State Pacemaker/ICD/CRT non-implanted components can be separate pieces or integrated and usually include housings, electronics, processors, software, connectors, and cables.
Technical Method Pacemaker/ICD/CRT non-implanted components transmit data from the implanted device to the health care provider using telemetry download, and direct or remote transmission.
Target Area Pacemaker/ICD/CRT devices are intended to provide therapy to the heart. The non-implanted components support the implanted devices.
Review Panel Cardiovascular
Product CodeOSR
Premarket Review Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
-
-