{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "ONU",
      "openfda": {
        "pma_number": [
          "P130024",
          "P160049",
          "P210039",
          "P190019",
          "P210025",
          "P140010"
        ],
        "registration_number": [
          "3005969022",
          "3005111382",
          "3002807314",
          "1000121056",
          "3013556777",
          "2011171",
          "2183744",
          "3009999323",
          "3001374820",
          "9681260",
          "3009380063",
          "3012102437",
          "2134265",
          "2124215",
          "1313046",
          "3005994106",
          "2953200",
          "3010273872",
          "3006513822",
          "3014687026",
          "9612164",
          "3006946276",
          "1319639",
          "3015190176",
          "1225687",
          "2030598",
          "3016257349"
        ],
        "fei_number": [
          "3005969022",
          "1000138054",
          "3005111382",
          "3002807314",
          "1000121056",
          "3001451463",
          "3013556777",
          "3002806565",
          "2011171",
          "2183744",
          "3009999323",
          "3001374820",
          "3009380063",
          "3012102437",
          "1000518731",
          "2124215",
          "1313046",
          "3001452571",
          "3005994106",
          "3010273872",
          "3006513822",
          "3014687026",
          "3006946276",
          "3002806434",
          "3002095335",
          "3015190176",
          "3016257349"
        ]
      },
      "review_panel": "CV",
      "medical_specialty": "",
      "device_name": "Drug-Eluting Peripheral Transluminal Angioplasty Catheter",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "3",
      "definition": "A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral.",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "2"
    }
  ]
}