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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 AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS
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 NumberS016
Date Received06/07/2002
Decision Date04/22/2003
Product Code DRF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES IN THE STERILIZATION CYCLE PARAMETERS.
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