|Trade Name||VARIOUS FAMILIES OF CRT-ICD'S|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Generic Name||cardiac resynchronization therapy|
|Supplement Type||real-time process|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change of three components used in the manufacturing o 2490c medtronic carelink monitor. The components being changed are the voltage controlled oscillator (vcxo) and two capacitors. Those are: 1) the vcxo provides an output frequency in response to a given voltage input. For the 2490c medtronic carelink monitor the vcxo supports the telemetry feature of the monitor. The same manufacturer provides both the original part (part number csx750vcb20. 000mut) and the new part (part number csx750vjb20. 000mut). 2) there are two capacitors being changed. The capacitor at location c230 is changing from 3300 pf to 6800 pf. The capacitor at location c277 is changing from 470 pf to 6800 pf. Both the current capacitors and the new capacitors are provided by the same manufacturer.