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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.
 
DeviceTactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE)
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantABBOTT MEDICAL
5050 Nathan Ln. N.
Plymouth, MN 55442
PMA NumberP220013
Supplement NumberS018
Date Received03/14/2025
Decision Date04/11/2025
Product Code 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  
a modification to the magnetic sensor manufacturing process to support more flexible sourcing
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