{
  "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": "2026-10-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "pma_number": "P070008",
      "supplement_number": "",
      "applicant": "Biotronik, Inc.",
      "street_1": "6024 Jean Rd.",
      "street_2": "",
      "city": "Lake Oswego",
      "state": "OR",
      "zip": "97035",
      "zip_ext": "",
      "generic_name": "Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)",
      "trade_name": "STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD",
      "product_code": "NKE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2007-03-12",
      "decision_date": "2008-05-12",
      "docket_number": "08M-0335",
      "fed_reg_notice_date": "2008-06-05",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE STRATOS LV CRT-P AND STRATOS LV-T CRT-P WITH 702.U PROGRAMMER SOFTWARE FOR THE ICS 3000 AND COROX OTW BP LEAD AND COROX OTW-S BP LEAD. THE STRATOS LV CRT-P AND THE STRATOS LV-T CRT-P ARE INDICATED FOR PATIENTS WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS II1/IV), INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF< 35%) AND QRS > 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY. THE COROX OTW BP AND COROX OTW-S BP LEFT VENTRICULAR PACING LEADS ARE BIPOLAR STEROID-ELUTING LEADS, INTENDED FOR PERMANENT IMPLANTATION IN THE LEFT VENTRICLE VIA THE CORONARY VEINS TO PROVIDE PACING AND/OR SENSING WHEN USED IN CONJUNCTION WITH A COMPATIBLE IS-1 PULSE GENERATOR.",
      "openfda": {
        "registration_number": [
          "9616693",
          "3006705815",
          "3033257494",
          "3005334138",
          "2649622",
          "2017865",
          "9610139",
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          "3008483389",
          "2124215",
          "3009380063",
          "3008494315",
          "2135338",
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          "1028232",
          "3013500228",
          "2032521",
          "3013288201",
          "1220452",
          "2182208",
          "3013596024",
          "2133641",
          "3003120897",
          "9614453",
          "3012552532"
        ],
        "fei_number": [
          "3002618605",
          "3006705815",
          "3033257494",
          "3005334138",
          "2649622",
          "2017865",
          "3000203466",
          "3015453963",
          "3008483389",
          "2124215",
          "3009380063",
          "3003574398",
          "3005700659",
          "3002807576",
          "3008377825",
          "3002806500",
          "3018094310",
          "1028232",
          "3013500228",
          "3013288201",
          "1220452",
          "2182208",
          "3013596024",
          "3003120897",
          "3012552532"
        ],
        "device_name": "Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}