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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 DS, Celsius DS, EZ Steer DS Bi-directional non nav, EZ Steer Nav DS Bi-directional, Celsius FLTR Uni-directiona
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP010068
Supplement NumberS062
Date Received03/02/2021
Decision Date04/07/2021
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of warnings from other catheter lines and the clarification of existing warnings and instructions.
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