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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP010031
Supplement NumberS068
Date Received05/21/2007
Decision Date06/14/2007
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product 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.