{
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-12",
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      "pma_number": "P160007",
      "supplement_number": "S006",
      "applicant": "Medtronic Minimed",
      "street_1": "18000 Devonshire St.",
      "street_2": "",
      "city": "Northridge",
      "state": "CA",
      "zip": "91325",
      "zip_ext": "",
      "generic_name": "Sensor, glucose, invasive",
      "trade_name": "Guardian Connect System",
      "product_code": "MDS",
      "advisory_committee": "CH",
      "advisory_committee_description": "Clinical Chemistry",
      "supplement_type": "Special (Immediate Track)",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2018-06-07",
      "decision_date": "2018-06-28",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for the addition of two 100% visual inspections to the needle hub assembly used in the Guardian Sensor (3) and Enlite Glucose Sensor.  The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System.  The Enlite Sensor is a component of the MiniMed 530G System, Paradigm Real-Time Revel System, MiniMed 630G System With SmartGuard, and MiniMed iPro2 CGM System with Enlite Sensor.",
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        "medical_specialty_description": "Unknown",
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