{
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    "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",
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      "applicant": "Medtronic, Inc.",
      "street_1": "8200 Coral Sea St. N.E",
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      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
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      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
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      "expedited_review_flag": "N",
      "date_received": "2023-05-05",
      "decision_date": "2023-12-13",
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      "decision_code": "APPR",
      "ao_statement": "Approval for the PulseSelect™ Pulsed Field Ablation (PFA) System. This device is indicated for cardiac electrophysiological mapping (stimulation and recording) and for treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation (episode duration less than 1 year).",
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