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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.
 
DeviceDIAGNOSTIC/ABLATION DEFLECTABLE BRAIDED-TIP CATHETER (WITHOUT THERMOCOUPLE) & CELSIUS (WITH THERMOCOUPLE)
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 NumberS002
Date Received03/23/1998
Decision Date07/22/1998
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 the 7 Fr and 8 Fr braided tip version of the Diagnostic/Ablation Deflectable Tip Catheter (with and without temperature sensors).
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