{
  "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": 27
    }
  },
  "results": [
    {
      "pma_number": "P160029",
      "supplement_number": "S011",
      "applicant": "Philips Medical Systems, Inc.",
      "street_1": "22100 Bothell-Everett Hwy.",
      "street_2": "",
      "city": "Bothell",
      "state": "WA",
      "zip": "98021",
      "zip_ext": "",
      "generic_name": "Over-the-counter automated external defibrillator",
      "trade_name": "HeartStart Home Defibrillator and HeartStart Onsite Defibrillator",
      "product_code": "NSA",
      "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": "2021-03-22",
      "decision_date": "2021-04-19",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "Change to the audio production test manufacturing specification performed during the Final Acceptance Test.",
      "openfda": {
        "registration_number": [
          "3009077524",
          "1930027",
          "3012607778",
          "3000126629",
          "3004123209",
          "3006108746",
          "3011823740",
          "3030677"
        ],
        "fei_number": [
          "3009077524",
          "1930027",
          "3012607778",
          "3000126629",
          "3004123209",
          "3006108746",
          "3011823740",
          "1000524572"
        ],
        "device_name": "Over-The-Counter Automated External Defibrillator",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5310",
        "device_class": "3"
      }
    }
  ]
}