{
  "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",
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      "supplement_number": "S061",
      "applicant": "ABBOTT MEDICAL",
      "street_1": "15900 Valley View Ct.",
      "street_2": "",
      "city": "Sylmar",
      "state": "CA",
      "zip": "91335",
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      "generic_name": "Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)",
      "trade_name": "FRONTIER/FRONTIER II FAMILY OF CRT-PS",
      "product_code": "NKE",
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      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2009-09-28",
      "decision_date": "2009-10-28",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "CHANGE IN THE TEST COVERAGE RANGE FOR THE GIANT MAGNETO RESISTANCE (GMR) COMPONENT.",
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        "medical_specialty_description": "Unknown",
        "regulation_number": "",
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