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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™
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantABBOTT MEDICAL
5050 Nathan Ln. N.
Plymouth, MN 55442
PMA NumberP220013
Supplement NumberS034
Date Received08/10/2026
Decision Date09/22/2026
Product Code OAE 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedYes
Approval Order Statement  
approval for a predetermined change control plan (PCCP) TactiFlex Ablation Catheter, Sensor Enabled Predetermined Change Control Plan Version A that encompasses the change to the manufacturing location of the deflectable subassembly for subject catheter.
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