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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 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
Predetermined Change Control Plan AuthorizedNo
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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