{
  "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": "2026-11-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 199
    }
  },
  "results": [
    {
      "pma_number": "P010030",
      "supplement_number": "S053",
      "applicant": "Zoll Manufacturing Corporation",
      "street_1": "121 Gamma Dr.",
      "street_2": "",
      "city": "Pittsburgh",
      "state": "PA",
      "zip": "15238",
      "zip_ext": "",
      "generic_name": "Wearable automated external defibrillator",
      "trade_name": "LIFEVEST WEARABLE DEFIBRILLATOR",
      "product_code": "MVK",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2014-05-27",
      "decision_date": "2015-11-06",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE LIFEVEST WEARABLE DEFIBRILLATOR 4000 AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.  THE DEVICE AS MODIFIED IS APPROVED FOR 1) CHANGE TO THE LENGTH OF THE THERAPY ELECTRODE CHANNEL FOAM; 2) CHANGE TO THE DIMENSIONAL TOLERANCES OF THE HOLE LOCATIONS ON THE THERAPY ELECTRODELIDDING LAYER;3) CHANGE FROM ADHESIVE TO CRIMPING OF THE BATTERY CONNECTOR AND REINFORCEMENT OF THE BATTERY CELLS WITHIN THE WCD 4000 PACK; AND4) CHANGE OF MATERIAL OF THE HEX NUT USED IN THE WCD 4000 MONITOR ELECTRODE BELTRECEPTACLE FROM BRASS TO STAINLESS STEEL.",
      "openfda": {
        "registration_number": [
          "1218058",
          "2133641",
          "3015185344",
          "1927395",
          "3027605722",
          "2135338",
          "1930027",
          "1220908",
          "2031044",
          "3008642652"
        ],
        "fei_number": [
          "1218058",
          "3005700659",
          "3015185344",
          "3000203466",
          "1927395",
          "3027605722",
          "1930027",
          "1220908",
          "3001236763",
          "3008642652"
        ],
        "device_name": "Wearable Automated External Defibrillator",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}