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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.
 
DeviceCELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Regulation Number870.1220
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP950005
Supplement NumberS010
Date Received12/08/2000
Decision Date10/05/2001
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR EXPANDING THE INDICATIONS FOR USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND IS INDICATED AS FOLLOWS: THE BIOSENSE WEBSTER CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORIES ARE INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH COMPATIBLE RADIOFREQUENCY GENERATORS IN ADULTS AND CHILDREN 4 YEARS OF AGE AND OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.
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