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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.
 
DeviceNAVISTAR RMT DS CATHETER
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP010068
Supplement NumberS009
Date Received01/31/2006
Decision Date03/21/2007
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDING REMOTE MAGNETIC NAVIGATION TECHNOLOGY TO THE PREVIOUSLY APPROVED CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NAVISTAR RMT DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGIC MAPPING (STIMULATION AND RECORDING), AND WHEN USED WITH THE STOCKERT 70 RADIOFREQUENCY GENERATOR (WITH SOFTWARE VERSION 001/033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS 18 OR OLDER. THE NAVISTAR RMT DS CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO RMT EP NAVIGATION SYSTEM. THE NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE CATHETER IS ONLY FOR USE WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS). COMPATIBILITY WITH THE STEREOTAXIS CARDIODRIVE HAS NOT BEEN DETERMINED.
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