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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.
 
DeviceVISITAG SURPOINT™ External Processing Unit (“EPU”); CARTO 3 System
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS143
Date Received04/01/2026
Decision Date06/30/2026
Product Code OAD 
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 AuthorizedYes
Approval Order Statement  
approval for the Connection Interface Unit (CIU) to be used with the TRUPULSE™ Generator, to introduce a predetermined change control plan (PCCP) (Predetermined Change Control Plan TRUPULSE™ Generator System Version 1.0) for planned hardware and software changes to the TRUPULSE™ Generator and related labeling updates
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