{
  "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": 1
    }
  },
  "results": [
    {
      "pma_number": "P080006",
      "supplement_number": "S192",
      "applicant": "Medtronic, Inc.",
      "street_1": "710 Medtronic Pkwy. NE",
      "street_2": "",
      "city": "Minneapolis",
      "state": "MN",
      "zip": "55432",
      "zip_ext": "",
      "generic_name": "Drug eluting permanent left ventricular (lv) pacemaker electrode",
      "trade_name": "Attain Ability Lead, Attain Performa Lead (4398,4598), Attain Performa Lead (4298), Attain Stability Quad MRI Lead",
      "product_code": "OJX",
      "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": "2026-03-31",
      "decision_date": "2026-04-15",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "to reduce the bioburden monitoring frequency from bi-weekly to monthly",
      "openfda": {
        "registration_number": [
          "9610139",
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3009380063",
          "2649622",
          "1220452",
          "2133641",
          "2030624",
          "1028232",
          "2648729",
          "3008494315",
          "3013500228",
          "9614453",
          "3012552532",
          "9616693",
          "2032521",
          "3013288201",
          "3013596024",
          "3018094310"
        ],
        "fei_number": [
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3009380063",
          "2649622",
          "1220452",
          "3000203466",
          "3002806500",
          "1028232",
          "2648729",
          "3013500228",
          "3012552532",
          "3002618605",
          "3003574398",
          "3000206435",
          "3013288201",
          "3013596024",
          "3008377825",
          "3018094310",
          "3002807576"
        ],
        "device_name": "Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}