Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
DeviceVolt™ PFA System
Generic NamePercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
ApplicantAbbott Medical
5050 Nathan Lane N.
Plymouth, Mn, MN 55442
PMA NumberP250022
Date Received06/27/2025
Decision Date12/19/2025
Product Code QZI 
Advisory Committee Cardiovascular
Clinical TrialsNCT06223789
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the Volt™ PFA System. This device is indicated for: The Volt™ PFA Catheter, Sensor Enabled™ is indicated for the treatment of symptomatic, recurrent, drug-refractory paroxysmal or persistent (episode duration less than one year) atrial fibrillation when used in conjunction with a compatible pulsed field ablation (PFA) generator. The catheter is compatible with the EnSite™ X EP System. The Current™ PFA Generator is indicated for use with compatible ablation catheters for the treatment of cardiac arrhythmias.
Approval OrderApproval Order
Post-Approval StudyShow Report Schedule and Study Progress
-
-