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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 NameMEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
Applicant MEDTRONIC INC.
PMA NumberP930029
Supplement NumberS021
Date Received12/10/2003
Decision Date02/05/2004
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a line extension to the commercially available rf enhancr catheter line with the changes limited to a new handle design and associated packaging changes. The device, as modified, will be marketed under the trade name medtronic rf enhancr ii family of ablation catheters and is indicated for use with the medtronic rf power generator to deliver rf energy for intracardiac ablation of accessory atrioventricular (av) conduction pathways associated with tachycardia for the treatment of av nodal re-entrant tachycardia and for creation of complete av block in patients with a difficult to control ventricular response to an atrial arrhythmia.
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