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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 NameEZ STEER THERMOCOOL AND
Classification Namecardiac ablation percutaneous catheter
Generic Namedrf(21 cfr 870.1220)
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP040036
Supplement NumberS006
Date Received11/23/2007
Decision Date09/30/2008
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 incorporation of a bidirectional deflection mechanism in the navistar thermocool and celsius thermocool catheters. The device, as modified, will be marketed under the trade name ez steer thermocool and ez steer thermocool nav catheters and indicated for treatment of type i atrial flutter and recurrent drug/device refractory sustained monomorphic ventricular tachycardia.
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