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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.
 
DeviceQWIKSTAR DS DIAGNOSTIC/ABLATION 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 NumberS002
Date Received11/03/2003
Decision Date01/14/2004
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS MAD TO THE NAVISTAR DS 8MM TIP DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER APPROVED UNDER P010068 AND THE QWIKSTAR 4 MM DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER APPROVED UNDER P990025/S004. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QWIKSTAR DS DIAGNOSTIC/ABLATION CATHETER AND IS INDICATED FOR CATHETER BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING) AND WHEN USED WITH THE STOCKERT 70 RF GENERATOR (SOFTWARE VERSION 1.033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS 18 YEARS OR OLDER.
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