{
  "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": "P230022",
      "supplement_number": "",
      "applicant": "Element Science, Inc.",
      "street_1": "301 Chesapeake Dr.",
      "street_2": "",
      "city": "Redwood City",
      "state": "CA",
      "zip": "94063",
      "zip_ext": "",
      "generic_name": "Wearable automated external defibrillator",
      "trade_name": "Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati",
      "product_code": "MVK",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2023-07-03",
      "decision_date": "2025-04-30",
      "docket_number": "FDA-7380",
      "fed_reg_notice_date": "2025-12-29",
      "decision_code": "APPR",
      "ao_statement": "Approval for the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (\"Jewel\"), Jewel P-WCD Firmware, Device Accessories Skin Preparation Kit, Placement Accessory, Device Removal Kit, Optional Software Accessories ES Mobile Application, ES Cloud, ES Report Generator, ES Clinical Portal. The Jewel P-WCD is indicated for adult patients 18 years of age and older who are at risk for Sudden Cardiac Arrest, and either are not candidates for or refuse an Implantable Defibrillator.",
      "openfda": {
        "registration_number": [
          "3027605722",
          "1927395",
          "1218058",
          "1220908",
          "2031044",
          "2133641",
          "3008642652",
          "2135338",
          "3015185344",
          "1930027"
        ],
        "fei_number": [
          "3001236763",
          "3000203466",
          "3027605722",
          "1927395",
          "1218058",
          "1220908",
          "3008642652",
          "3005700659",
          "3015185344",
          "1930027"
        ],
        "device_name": "Wearable Automated External Defibrillator",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}