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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.
 
DeviceFARAWAVE Pulsed Field Ablation Catheter
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 NumberS006
Date Received09/24/2024
Decision Date10/24/2024
Product Code QZI 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
updates to the catheter shaft manufacturing process for the FARAWAVE Pulsed Field Ablation (PFA) Catheter
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