||pacemaker/icd/crt non-implanted components|
||Pacemaker/icd/crt non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
||Pacemaker/ICD/CRT non-implanted components can be separate pieces or integrated and usually include housings, electronics, processors, software, connectors, and cables.
||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.
||Pacemaker/ICD/CRT devices are intended to provide therapy to the heart. The non-implanted components support the implanted devices.
Office of Device Evaluation
Division of Cardiovascular Devices
Implantable Electrophysical Devices Branch (IEDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible