{
  "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": "2026-07-27",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "pma_number": "P220029",
      "supplement_number": "",
      "applicant": "Urotronic, Inc.",
      "street_1": "2495 Xenium Ln.",
      "street_2": "",
      "city": "Minneapolis",
      "state": "MN",
      "zip": "55449",
      "zip_ext": "",
      "generic_name": "Drug coated prostatic dilation catheter for benign prostatic hyperplasia",
      "trade_name": "Optilume™ BPH Catheter System",
      "product_code": "QXB",
      "advisory_committee": "GU",
      "advisory_committee_description": "Gastroenterology, Urology",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2022-12-12",
      "decision_date": "2023-06-30",
      "docket_number": "23M-2744",
      "fed_reg_notice_date": "2023-07-07",
      "decision_code": "APPR",
      "ao_statement": "Approval for the Optilume BPH Catheter System indicated for the treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH) in men >= 50 years of age.",
      "openfda": {
        "device_name": "Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3015228875",
          "2183744"
        ],
        "fei_number": [
          "3015228875",
          "2183744"
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      }
    }
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}