{
  "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",
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      "pma_number": "P150005",
      "supplement_number": "S074",
      "applicant": "Boston Scientific Corp",
      "street_1": "4100 Hamline Ave. N",
      "street_2": "",
      "city": "St Paul",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
      "trade_name": "INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Panel Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2023-02-03",
      "decision_date": "2024-02-26",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping SystemThe INTELLANAV STABLEPOINT Catheter, when used with a compatible Radiofrequency Controller and IrrigationPump, is indicated for:• Cardiac electrophysiological mapping• Delivering diagnostic pacing stimuli• RF ablation of sustained or recurrent typical atrial flutter in patients age 18 years or older• Treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system",
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        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation",
        "medical_specialty_description": "Unknown",
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        "device_class": "3"
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