{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "pma_number": "P230022",
      "supplement_number": "S004",
      "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": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Postapproval Study Protocol",
      "expedited_review_flag": "N",
      "date_received": "2025-10-30",
      "decision_date": "2025-11-19",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230022.",
      "openfda": {
        "registration_number": [
          "1927395",
          "1220908",
          "3027605722",
          "1218058",
          "2133641",
          "1930027",
          "2031044",
          "2135338",
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          "3000203466",
          "1930027",
          "3005700659",
          "3015185344",
          "3008642652"
        ],
        "device_name": "Wearable Automated External Defibrillator",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}