{
  "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": "2026-10-12",
    "results": {
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      "supplement_number": "S070",
      "applicant": "St Jude Medical",
      "street_1": "One St. Jude Medical Dr.",
      "street_2": "",
      "city": "St. Paul",
      "state": "MN",
      "zip": "55117",
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      "trade_name": "TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Panel Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2021-04-01",
      "decision_date": "2021-11-04",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the TactiCath Contact Force Ablation Catheter, Sensor Enabled.  The device is indicated for use in cardiac electrophysiology mapping and for the treatment of drug refractory recurrent symptomatic, paroxysmal, and persistent atrial fibrillation, when used in conjunction with a compatible RF generator and three-dimensional mapping system.",
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        "medical_specialty_description": "Unknown",
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