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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 BI-DIRECTIONAL NAVIGATION CATHETER; QDOT MICRO UNI-DIRECTIONAL NAVIGATION CATHETER
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP210027
Supplement NumberS019
Date Received08/18/2026
Decision Date09/15/2026
Product Codes OAD OAE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
an additional supplier for critical components
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