{
  "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": "2026-10-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 23
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  "results": [
    {
      "pma_number": "P230007",
      "supplement_number": "S016",
      "applicant": "ABBOTT MEDICAL",
      "street_1": "177 County Rd. B E.",
      "street_2": "",
      "city": "St. Paul",
      "state": "MN",
      "zip": "55117",
      "zip_ext": "",
      "generic_name": "Tricuspid valve repair device, percutaneously delivered",
      "trade_name": "TriClip Delivery System",
      "product_code": "NPS",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2025-07-21",
      "decision_date": "2025-08-18",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "to change the incoming inspection sampling plan for components of the TriClip and MitraClip Delivery Systems from an Attribute Acceptable Quality Limit (AQL) to a variable-based plan with custom sampling plan requirements",
      "openfda": {
        "device_name": "Tricuspid Valve Repair Device, Percutaneously Delivered",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3007113487",
          "3005070406",
          "2135147"
        ],
        "fei_number": [
          "3007113487",
          "3005070406",
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}