{
  "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": "2026-07-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 24
    }
  },
  "results": [
    {
      "pma_number": "P200039",
      "supplement_number": "S001",
      "applicant": "Shockwave Medical, Inc.",
      "street_1": "5403 Betsy Ross Dr.",
      "street_2": "",
      "city": "Santa Clara",
      "state": "CA",
      "zip": "95054",
      "zip_ext": "",
      "generic_name": "Shockwave intravascular lithotripsy system",
      "trade_name": "Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter",
      "product_code": "QMG",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Postapproval Study Protocol",
      "expedited_review_flag": "N",
      "date_received": "2021-03-10",
      "decision_date": "2021-04-09",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for transition to continued follow up study.",
      "openfda": {
        "registration_number": [
          "3010086866",
          "3005092783",
          "3007738736",
          "3004363082",
          "3015053858",
          "2030598",
          "3027545377",
          "3012102437"
        ],
        "fei_number": [
          "3010086866",
          "3005092783",
          "3007738736",
          "3004363082",
          "3015053858",
          "1000518731",
          "3027545377",
          "3012102437"
        ],
        "device_name": "Shockwave Intravascular Lithotripsy System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}