{
  "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": "P210020",
      "supplement_number": "",
      "applicant": "Urotronic, Inc.",
      "street_1": "2495 Xenium Ln.",
      "street_2": "",
      "city": "Minneapolis",
      "state": "MN",
      "zip": "55441",
      "zip_ext": "",
      "generic_name": "Catheter, Balloon, Urethral, Drug-Coated",
      "trade_name": "Optilume Urethral Drug Coated Balloon",
      "product_code": "QRH",
      "advisory_committee": "GU",
      "advisory_committee_description": "Gastroenterology, Urology",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2021-05-11",
      "decision_date": "2021-12-03",
      "docket_number": "21M-1284",
      "fed_reg_notice_date": "2021-12-09",
      "decision_code": "APPR",
      "ao_statement": "Approval of the Optilume® Urethral Drug Coated Balloon.  The device  is used to treat patients with obstructive urinary symptoms associated with anterior urethral stricture. It is designed to be used in adult males for urethral strictures of less than or equal to 3 cm in length.",
      "openfda": {
        "device_name": "Catheter, Balloon, Urethral, Drug-Coated",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3015228875",
          "3002647932",
          "2183744"
        ],
        "fei_number": [
          "3015228875",
          "3002647932",
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}