{
  "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": "P150012",
      "supplement_number": "S184",
      "applicant": "Boston Scientific",
      "street_1": "4100 Hamline Ave. N",
      "street_2": "",
      "city": "St Paul",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Implantable pulse generator, pacemaker (non-CRT)",
      "trade_name": "INGEVITY™ MRI; INGEVITY™+; INGEVITY™+ Passive",
      "product_code": "LWP",
      "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": "2026-04-22",
      "decision_date": "2026-05-19",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "a new rework process to de-adhere suture sleeve from lead body",
      "openfda": {
        "device_name": "Implantable Pulse Generator, Pacemaker (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "9610139",
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3008483389",
          "3009380063",
          "3004209178",
          "1000165971",
          "2649622",
          "1220452",
          "3003932293",
          "1450662",
          "3003120897",
          "2135338",
          "2133641",
          "3008159616",
          "2024024",
          "3033257494",
          "1028232",
          "2648729",
          "3005334138",
          "3008494315",
          "3013500228",
          "9614453",
          "3012552532",
          "3008973940",
          "9616693",
          "2032521",
          "1721676",
          "3002806603",
          "3013288201",
          "3013596024",
          "3018094310",
          "3004105270"
        ],
        "fei_number": [
          "2182208",
          "2124215",
          "3006705815",
          "2017865",
          "3004369318",
          "3008483389",
          "3009380063",
          "1000165971",
          "2649622",
          "1220452",
          "3003932293",
          "3000203466",
          "1450662",
          "3003120897",
          "3008159616",
          "2024024",
          "3002806500",
          "3033257494",
          "1028232",
          "2648729",
          "3005334138",
          "3013500228",
          "3005700659",
          "3012552532",
          "3008973940",
          "3002618605",
          "3003574398",
          "1721676",
          "3002806603",
          "3013288201",
          "3013596024",
          "3008377825",
          "3018094310",
          "3004105270",
          "3002807576"
        ]
      }
    }
  ]
}