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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.
 
DeviceMAGiC Ablation Catheter
Generic NameCardiac ablation percutaneous catheter
ApplicantStereotaxis, Inc.
710 Tucker Blvd.
Suite 110
Saint Louis, MO 63101
PMA NumberP240014
Supplement NumberS001
Date Received02/04/2026
Decision Date07/31/2026
Product Code LPB 
Advisory Committee Cardiovascular
Clinical TrialsNCT06019845
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240014.
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