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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
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP990025
Supplement NumberS067
Date Received06/30/2021
Decision Date03/08/2022
Product Code DRF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the nGEN Generator (compatible with the THERMOCOOL, NAVISTAR and CELSIUS catheters), the addition of a manufacturing site in Israel to manufacture the nGEN Generator and nGEN Pump, and the addition of a manufacturing site in Mexico to manufacture the Interface Cable between the CELSIUS catheters to the nGEN Generator.
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