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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 RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S
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 NumberS018
Date Received09/28/2004
Decision Date12/16/2005
Product Code DRF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGIC MAPPING AND FOR USE WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS) AND COMPATIBLE RADIOFREQUENCY GENERATORS IN ADULTS AND CHILDREN FOUR (4) YEARS OF AGE OR OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.
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