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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.
 
DeviceVOLT™ PFA CATHETER, SENSOR ENABLED™
Generic NamePercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
ApplicantABBOTT MEDICAL
5050 Nathan Ln. N.
Plymouth, MN 55442
PMA NumberP250022
Supplement NumberS007
Date Received05/28/2026
Decision Date06/22/2026
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  
the introduction of mainline manufacturing activities in an ISO 9 controlled access environment
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