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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 Namecardiac ablation percutaneous catheter
Generic Nameradiofrequency generator and accessories/accessory cable
PMA NumberP990071
Supplement NumberS016
Date Received01/04/2012
Decision Date10/31/2012
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for upgrading the existing accessory coolflow irrigation pump for the stockert 70 radiofrequency (rf) generator for cardiac ablation. The device, as modified, will be marketed under the trade name smartablate irrigation pump and smartablate tubing set. The indications are that the smartablate irrigation pump is a peristaltic pump designed to work in conjunction with the stockert 70 radiofrequency generator to deliver irrigation solution at specified now rates to irrigated catheters (such as the biosense webster celsius thermocool catheters and navistar thermocool catheters) for cooling purposes. The pump is used with the smartablate irrigation tubing set that conducts the irrigation solution from an external source to the compatible irrigated catheters.