{
  "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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      "supplement_number": "S001",
      "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 Catheter Sensor Enabled™",
      "product_code": "QZI",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2025-12-23",
      "decision_date": "2026-03-23",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval for minor design modifications, addition of Alajuela, Costa Rica as a manufacturing site, addition of Minnetonka, Minnesota as a basket subassembly manufacturing site, and addition of two Ethylene Oxide sterilization sites. Additionally, you requested approval for a Pre-Determined Change Control Plan (PCCP) that establishes updates to component suppliers for second source components for the balloon, splines, and center lumen of the catheter, provided they do not impact the specifications, the established methods for its sourcing, handling, and testing, or the qualification standards for supplier facilities and personnel for the devices under the above PMA.",
      "openfda": {
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        "regulation_number": "",
        "device_class": "3",
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