{
  "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": "2026-11-02",
    "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": "OOB",
      "openfda": {
        "pma_number": [
          "P250041",
          "P230035"
        ],
        "registration_number": [
          "3012102437",
          "2134265",
          "2030598",
          "1225687",
          "2124215",
          "3015190176",
          "3005969022",
          "9681260"
        ],
        "fei_number": [
          "3012102437",
          "3002806565",
          "3001451463",
          "3002095335",
          "1000518731",
          "2124215",
          "3015190176",
          "3005969022"
        ]
      },
      "review_panel": "CV",
      "medical_specialty": "",
      "device_name": "Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "3",
      "definition": "A drug-eluting percutaneous transluminal coronary angioplasty catheter is a combination product intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.  A drug-eluting ptca catheter may also be intended for the treatment of acute myocardial infarction; Treatment of in-stent restenosis (isr) and/or post-deployment stent expansion.  A drug-eluting ptca catheter delivers a drug to the vessel as part of the angioplasty procedure, which is intended to inhibit restenosis.",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "2"
    }
  ]
}