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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.
 
DeviceFARAPULSE™ Pulsed Field Ablation System (FARAPULSE)
Generic NamePercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
ApplicantFarapulse, Inc.
3715 Haven Ave.
Suite 110
Menlo Park, CA 94025
PMA NumberP230030
Supplement NumberS022
Date Received06/10/2026
Decision Date07/10/2026
Product Code QZI 
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  
two manufacturing changes to be implemented at the supplier
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