{
  "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": {
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    {
      "pma_number": "P050023",
      "supplement_number": "S211",
      "applicant": "Biotronik, Inc.",
      "street_1": "6024 Jean Rd.",
      "street_2": "",
      "city": "Lake Oswego",
      "state": "OR",
      "zip": "97035",
      "zip_ext": "",
      "generic_name": "DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER",
      "trade_name": "PSW 2601.U, NEO 2601.U, Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP, R",
      "product_code": "MRM",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Real-Time Process",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "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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        "medical_specialty_description": "Unknown",
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