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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.
 
DeviceAFR-00004 HexaGen RF Generator (RFG) and AFR-00008 HexaPulse PF Generator (PFG)
Generic NamePercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP240013
Supplement NumberS008
Date Received05/06/2025
Decision Date08/01/2025
Product Codes OAD OAE QZI 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for hardware and firmware changes to the Affera Ablation System AFR-00008 HexaPulse PF Generator (PFG) and an enabling software change to the Affera Ablation System AFR-00004 HexaGen RF Generator (RFG)
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