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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceQDOT MICRO™ System
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantBiosense Webster, Inc.
31 technology drive, suite 200
irvine, CA 92618
PMA NumberP210027
Date Received07/06/2021
Decision Date11/23/2022
Product Codes OAD OAE 
Advisory Committee Cardiovascular
Clinical TrialsNCT03775512
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Biosense Webster QDOT MICRO Catheter and related accessory devices. The device is indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF generator, for the treatment of:1) Type I atrial flutter in patients age 18 or older; and2) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The QDOT MICRO Catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with CARTO® 3 Navigation System.