| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | QDOT MICRO™ System |
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| Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
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| Applicant | Biosense Webster, Inc.
31 Technology Drive, Suite 200
Irvine, CA 92618 |
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| PMA Number | P210027 |
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| Date Received | 07/06/2021 |
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| Decision Date | 11/23/2022 |
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| Product Codes |
OAD OAE |
| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT03775512
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012
S013 S014 S015 |
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