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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 Namesystem,pacing,temporary,acute,internal atrial defibrillation
Generic Namecardiac ablation catheter
PMA NumberP020052
Supplement NumberS001
Date Received07/15/2003
Decision Date08/22/2003
Product Code
MTE[ Registered Establishments with MTE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cardioversion switchbox ii system. The device is indicated as follows: the cardioversion switchbox ii system connects a st. Jude medical cardioversion (cv) catheter and extension cable to a compatible cardioverter/ defibrillator and ep recording system.