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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
Generic NamePercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
ApplicantFARAPULSE, Inc.
3715 Haven Avenue
Suite 110
Menlo Park, CA 94025
PMA NumberP230030
Supplement NumberS004
Date Received04/19/2024
Decision Date05/03/2024
Product Code QZI 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
a change to the electrical testing system of the FARASTAR generator used during manufacturing at the St. Paul facility
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