{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "pma_number": "P230030",
      "supplement_number": "S007",
      "applicant": "Farapulse, Inc.",
      "street_1": "3715 Haven Ave.",
      "street_2": "Suite 110",
      "city": "Menlo Park",
      "state": "CA",
      "zip": "94025",
      "zip_ext": "",
      "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
      "trade_name": "FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C",
      "product_code": "QZI",
      "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": "2024-11-25",
      "decision_date": "2025-07-03",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval for the FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, FARASTAR™ Pulsed Field Ablation Generator, FARASTAR™ Recording System Module, FARASTAR™ Mapping System Module, FARASTAR™ Stimulation Module Cable, FARASTAR™ EGM Cable, FARASTAR™ Stimulation Module Male Cable, FARASTAR™ Stimulation Module Female Cable, FARASTAR™ Stimulation Module Y-Cable Long, FARASTAR™ Stimulation Module Y-Cable Short, FARASTAR™ Recording System Module Catheter Pin Cable, FARASTAR™ Recording System Module ECG Trunk Cable, FARASTAR™ Recording System Module ECG Output Module (AAMI/IEC), FARASTAR™ Recording System Module EGM Input Module, FARASTAR™ SNAP CABLE R/L – (AAMI/IEC), FARASTAR™ SNAP CABLE V SET – (AAMI), FARASTAR™ SNAP CABLE C SET – (IEC), FARASTAR™ Recording System Module ECG Output to Rhythmia HDx™ ECG Input Cable, FARASTAR™ Recording System Module EGM Output to Rhythmia HDx™ EGM Input Cable, FARASTAR™ Mapping System Module Back Patch Cable, FARASTAR™ Mapping System Module Back Patch Cable Male, FARASTAR™ Mapping System Module BNC BNC-Phono Cable, FARASTAR™ Mapping System Module Rhythmia™ ABL Cable, FARASTAR™ Mapping System Module Auxiliary Cable) for expanding the indications to include the isolation of pulmonary veins and the posterior wall in the treatment of drug-refractory, symptomatic Persistent Atrial Fibrillation (episode duration less than one year).",
      "openfda": {
        "registration_number": [
          "3012693387",
          "3017060084",
          "3007029079",
          "3005334138",
          "3008452825",
          "1928237",
          "1721686",
          "3008093809",
          "3011120183",
          "9673241",
          "3001592626",
          "2124215",
          "2182269",
          "3009380063",
          "3000279201",
          "3007603855",
          "3005012805",
          "2183744",
          "1000121056",
          "3008328679",
          "3004593495",
          "3002807314",
          "3007648309",
          "3004859241",
          "3002648230",
          "3009243923",
          "9680579",
          "2024024",
          "3009504230",
          "3012520654",
          "3012263546",
          "3012260771",
          "3004016520",
          "3012179728",
          "3016245399",
          "2182208",
          "1319639",
          "1721983",
          "2184149",
          "9681260",
          "3013300026",
          "2032112",
          "3004105270",
          "3013403214",
          "9612164"
        ],
        "fei_number": [
          "3012693387",
          "3017060084",
          "3007029079",
          "3005334138",
          "3008452825",
          "1000203464",
          "1721686",
          "3008093809",
          "1928237",
          "3011120183",
          "1000138054",
          "3003248396",
          "3001592626",
          "2124215",
          "2182269",
          "3009380063",
          "3000279201",
          "3007603855",
          "3005012805",
          "2183744",
          "1000121056",
          "3008328679",
          "3004593495",
          "3002807314",
          "3003076831",
          "3007648309",
          "3004859241",
          "3002648230",
          "3002806434",
          "3009243923",
          "1000064530",
          "2024024",
          "3009504230",
          "3012520654",
          "3012263546",
          "3012260771",
          "3002806565",
          "1000139754",
          "3004016520",
          "3012179728",
          "3016245399",
          "2182208",
          "3013300026",
          "3004105270",
          "3013403214"
        ],
        "device_name": "Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}