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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 DS, NAVISTAR DS, EZ STEER DS and CELSIUS FLTR
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP950005
Supplement NumberS080
Date Received05/17/2021
Decision Date09/22/2021
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for updated labeling, including modified warnings and directions for use.
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