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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 MODEL 4806 ATAKR II RF POWER GENERATOR
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
Applicant MEDTRONIC INC.
PMA NumberP930029
Supplement NumberS013
Date Received02/29/2000
Decision Date11/27/2000
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 a new rf generator. The device, as modified, will be marketed under the trade name atakr ii and is indicated for interruption of accessory atrioventricular (av) conduction pathways associated with tachycardia, treatment of av nodal re-entrant tachycardia, and creation of complete av block in patients with a difficult to control ventricular response to an atrial arrhythmia.
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