{
  "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": "P980023",
      "supplement_number": "S147",
      "applicant": "Biotronik, Inc.",
      "street_1": "6024 Jean Rd.",
      "street_2": "",
      "city": "Lake Oswego",
      "state": "OR",
      "zip": "97035",
      "zip_ext": "",
      "generic_name": "Implantable cardioverter defibrillator (non-CRT)",
      "trade_name": "Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk",
      "product_code": "LWS",
      "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": "2026-05-27",
      "decision_date": "2026-06-24",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "the introduction of an alternate anchor welding machine",
      "openfda": {
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "9610139",
          "2022502",
          "2124215",
          "2182208",
          "2017865",
          "3006705815",
          "3009380063",
          "3004209178",
          "1000165971",
          "2011171",
          "2649622",
          "3011120183",
          "3003932293",
          "3014461810",
          "3003276151",
          "3003120897",
          "2135338",
          "2133641",
          "2030624",
          "1828132",
          "3008159616",
          "3033257494",
          "3002807561",
          "1028232",
          "2648729",
          "3005334138",
          "3008494315",
          "2183744",
          "3004961578",
          "1225687",
          "3013500228",
          "3004593495",
          "9614453",
          "3012552532",
          "3008973940",
          "9616693",
          "3010288227",
          "3015453963",
          "2032521",
          "1423662",
          "3013674629",
          "3008988055",
          "3010273872",
          "3015544746",
          "3002806603",
          "3013288201",
          "1000121056",
          "3013596024",
          "2183787",
          "3002807314",
          "3018094310",
          "3004105270"
        ],
        "fei_number": [
          "2022502",
          "2124215",
          "2182208",
          "2017865",
          "3004369318",
          "3006705815",
          "3009380063",
          "1000165971",
          "2011171",
          "2649622",
          "3011120183",
          "3003932293",
          "3014461810",
          "3000203466",
          "3003276151",
          "3003120897",
          "1828132",
          "3008159616",
          "3002806500",
          "3033257494",
          "3002807561",
          "1028232",
          "2648729",
          "3005334138",
          "2183744",
          "3004961578",
          "3013500228",
          "3004593495",
          "3005700659",
          "3012552532",
          "3008973940",
          "3002618605",
          "3003574398",
          "3010288227",
          "3015453963",
          "3001451463",
          "3000215273",
          "3000206435",
          "3013674629",
          "3008988055",
          "3010273872",
          "3015544746",
          "3002806603",
          "3013288201",
          "1000121056",
          "3013596024",
          "2183787",
          "3008377825",
          "3002807314",
          "3018094310",
          "3004105270",
          "3002807576"
        ]
      }
    }
  ]
}