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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.
 
DeviceNAVI-STAR 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 NumberP990025
Supplement NumberS003
Date Received12/21/2000
Decision Date01/11/2001
Product Code DRF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE POLYMERIC MIXTURE USED TO MANUFACTURE THE CATHETER'S TIP. THE CHANGE IS INTENDED TO STANDARDIZE PROCESSES ACROSS THE NAVI-STAR PRODUCT LINE.
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