{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-05",
    "results": {
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  "results": [
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      "pma_number": "P250022",
      "supplement_number": "",
      "applicant": "ABBOTT MEDICAL",
      "street_1": "5050 Nathan Ln. N.",
      "street_2": "",
      "city": "Plymouth",
      "state": "MN",
      "zip": "55442",
      "zip_ext": "",
      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
      "trade_name": "Volt™ PFA System",
      "product_code": "QZI",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2025-06-27",
      "decision_date": "2025-12-19",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_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.",
      "openfda": {
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        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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