{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "pma_number": "P230022",
      "supplement_number": "S006",
      "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": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2025-12-19",
      "decision_date": "2026-01-13",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "the use of an alternate supplier for a coating process",
      "openfda": {
        "device_name": "Wearable Automated External Defibrillator",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3008642652",
          "2135338",
          "3015185344",
          "2133641",
          "1930027",
          "1220908",
          "1218058",
          "3027605722",
          "1927395",
          "2031044"
        ],
        "fei_number": [
          "3008642652",
          "3015185344",
          "1930027",
          "3005700659",
          "1220908",
          "1218058",
          "3027605722",
          "1927395",
          "3001236763",
          "3000203466"
        ]
      }
    }
  ]
}