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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.
 
Trade NameSTOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency generator and accessories/accessory cable
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990071
Supplement NumberS005
Date Received12/22/2003
Decision Date06/06/2005
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manual operation of the coolflow irrigation pump with the biosense webster thermocool catheters. The device, as modified, will be marketed under the trade name coolflow irrigation pump. The coolflow irrigation pump and tubing set is a peristaltic irrigation pump designed for the delivery of saline solution when used in conjunction with the stockert 70 rf generator and the thermocool irrigation catheters.
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