{
  "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",
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      "supplement_number": "S291",
      "applicant": "Biotronik, Inc.",
      "street_1": "6024 Jean Rd.",
      "street_2": "",
      "city": "Lake Oswego",
      "state": "OR",
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      "generic_name": "implantable pacemaker Pulse-generator",
      "trade_name": "PSW 2601.U, NEO 2601.U, Amvia Sky HF-T QP, Amvia Sky HF-T, Amvia Edge HF-T QP, Amvia Sky DR-T, Amvia Sky SR-T, Amvia Edg",
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      "supplement_reason": "Change Design/Components/Specifications/Material",
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      "date_received": "2026-04-15",
      "decision_date": "2026-09-17",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval for updated programmer software PSW 2601.U and NEO 2601.U",
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