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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™ Duo Ablation Catheter, Sensor Enabled™ (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD, A-TFDM-DF, A-TFDM-FF, A-TFDM
ApplicantABBOTT MEDICAL
5050 Nathan Ln. N.
Plymouth, MN 55442
PMA NumberP220013
Supplement NumberS028
Date Received03/02/2026
Decision Date09/04/2026
Advisory Committee Cardiovascular
Clinical TrialsNCT06676072
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ is indicated for use in The TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ is indicated for use in cardiac electrophysiological mapping and ablation for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible radiofrequency (RF) or pulsed field (PF) generator and three-dimensional mapping system.
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