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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP930029
Supplement NumberS010
Date Received11/04/1997
Decision Date12/18/1997
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to implement design changes in the RF Performr catheter that will result in the ability of the catheter to deflect in two directions rather than one and the inclusion of a self reference electrode on some models. The device, as modified, will be marketed under the trade name the RF Conductr MC Self-Reference Catheters 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.