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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 DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP990025
Supplement NumberS002
Date Received12/11/2000
Decision Date09/26/2001
Product Code DRF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR EXPANDING THE INDICATIONS FOR USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NAVISTART DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER AND IS INDICATED A FOLLOWS: THE BIOSENSE WEBSTER NAVI-STAR DIAGNOSTIC/ABLATION CATHETER, AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGICAL MAPPING, AND FOR USE WITH A COMPATIBLE RF GENERATOR IN ADULTS AND CHILDREN 4 YEARS OF AGE AND OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS. WHEN USED WITH THE CARTO EP NAVIGATION SYSTEM, THE NAVI-STAR DIAGNOSTIC/ABLATION CATHETER PROVIDES LOCATION INFORMATION.
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