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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.
 
DeviceATAKR(R) RFCA ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
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/material
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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