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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 NameATAKR(R) RFCA ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
Applicant MEDTRONIC INC.
PMA NumberP930029
Supplement NumberS014
Date Received06/28/2000
Decision Date07/31/2000
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the tip electrode length (5 mm). The device, as modified, will be marketed under the trade name conductr(r) mc-5mm, and is indicated for the interruption 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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