{
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    "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",
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      "pma_number": "P950037",
      "supplement_number": "",
      "applicant": "Biotronik, Inc.",
      "street_1": "6024 Jean Rd.",
      "street_2": "",
      "city": "Lake Oswego",
      "state": "OR",
      "zip": "97035",
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      "generic_name": "implantable pacemaker Pulse-generator",
      "trade_name": "DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS",
      "product_code": "DXY",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "1995-11-16",
      "decision_date": "1996-10-11",
      "docket_number": "97M-0251",
      "fed_reg_notice_date": "1997-07-02",
      "decision_code": "APPR",
      "ao_statement": "RATE ADAPTIVE PACING WITH THE DROMOS DR AND DROMOS SR PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY",
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        "device_class": "3"
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}