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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 Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency generator and accessories/accessory cable
Regulation Number870.1220
PMA NumberP990071
Supplement NumberS004
Date Received11/05/2003
Decision Date02/24/2004
Product Code
DRF[ Registered Establishments with DRF ]
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 addition of a stockert remote control and connection cable. The device, as modified, will be marketed under the trade name stockert remote control and connection cable and is indicated for use in conjunction with the stockert 70 radiofrequency generator to be used in conjunction with a compatible catheter for cardiac ablation procedures.