{
  "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": {
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    {
      "pma_number": "P050023",
      "supplement_number": "S214",
      "applicant": "Biotronik, Inc.",
      "street_1": "6024 Jean Rd.",
      "street_2": "",
      "city": "Lake Oswego",
      "state": "OR",
      "zip": "97035",
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      "generic_name": "DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER",
      "trade_name": "Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP, Rivacor Sky HF-T QP, Riva",
      "product_code": "MRM",
      "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": "2026-08-27",
      "decision_date": "2026-09-25",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "to update manufacturing processes for high voltage capacitors in ICDs and CRT-Ds",
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        "medical_specialty_description": "Unknown",
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