{
  "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": [
    {
      "pma_number": "P030031",
      "supplement_number": "S141",
      "applicant": "Biosense Webster, Inc.",
      "street_1": "31 Technology Dr., Suite 200",
      "street_2": "",
      "city": "Irvine",
      "state": "CA",
      "zip": "92618",
      "zip_ext": "",
      "generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
      "trade_name": "Dual Energy THERMOCOOL SMARTTOUCH SF™ System",
      "product_code": "OAD",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Panel Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2025-09-25",
      "decision_date": "2026-07-01",
      "docket_number": "FDA-7604",
      "fed_reg_notice_date": "2026-07-08",
      "decision_code": "APPR",
      "ao_statement": "Approval for the Dual Energy THERMOCOOL SMARTTOUCH SF™ System. This device is indicated for:Dual Energy THERMOCOOL SMARTTOUCH™ SF CatheterThe Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible generator, for the treatment of:When using Radiofrequency (RF) energy Only:• Type I atrial flutter in patients age 18 or older.• Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.• Drug refractory recurrent symptomatic persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 1 year), refractory or intolerant to at least one Class I or III antiarrhythmic medicine, when used with compatible three-dimensional electroanatomic mapping systems.When using Pulsed Field (PF) energy:• Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.The Dual Energy THERMOCOOL SMARTTOUCH™ SF Navigation Catheter provides a real-time measurement of contact force between the catheter tip and the heart wall, as well as location information when used with the CARTO™ 3 System.nGEN™ PumpThe nGEN™ Pump is a peristaltic pump designed to work with a compatible irrigation tubing set, either independently or with a compatible generator, to deliver irrigation solution to compatible irrigated catheter.Sterile Interface CableThis cable provides a means to connect a Biosense Webster electrophysiology catheter to the appropriate equipment. The cable may be reused subject to the cleaning and sterilization restrictions detailed in Instructions for Use.",
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        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
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}