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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 Drive, Suite 200
Irvine, CA 92618
PMA NumberP210027
Supplement NumberS004
Date Received08/21/2023
Decision Date09/19/2023
Product Codes OAD OAE 
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 changes being made to the QDOT MICRO System Instructions for Use (IFU), part numbers M-5276-827 (QDOT MICRO Uni-Directional Navigation Catheter Instructions for Use) and M-5276-829 (QDOT MICRO Bi-Directional Navigation Catheter Instructions for Use).
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