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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 Nametester, pacemaker electrode function
Generic Nametester, pacemaker electrode function
Regulation Number870.3720
6024 jean road
lake oswego, OR 97035
PMA NumberP980023
Supplement NumberS009
Date Received06/04/2002
Decision Date11/25/2002
Product Code
DTA[ Registered Establishments with DTA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the kainox rv-s active fixation, single shock coil icd lead and the kainox vcs single shock coil icd lead for use as an adjunct to modify the shock configuration of icd systems. Together with legally marketed biotronik icds, these lead systems provide the patient with a system that is capable of detecting and treating ventricular tachyarrhythmias.