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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.
 
DeviceQDOT MICRO™ System
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP210027
Supplement NumberS012
Date Received07/24/2024
Decision Date04/08/2025
Product Codes OAE OAD 
Advisory Committee Cardiovascular
Clinical TrialsNCT03775512
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
PAS protocol changes to retrospectively consent patients enrolled in REAL-AF Sites and to include the Zero/Low Fluoro Workflow.
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