{
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    "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",
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      "pma_number": "P100009",
      "supplement_number": "S034",
      "applicant": "ABBOTT MEDICAL",
      "street_1": "177 County Rd. B E.",
      "street_2": "",
      "city": "St. Paul",
      "state": "MN",
      "zip": "55117",
      "zip_ext": "",
      "generic_name": "Mitral valve repair devices",
      "trade_name": "MitraClip NT, NTR, XTR, G4 Clip Delivery System",
      "product_code": "NKM",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Special (Immediate Track)",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2019-08-06",
      "decision_date": "2019-08-30",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for manufacturing process changes to reduce Clip Arm spread variability and to implement an inspection for final Clip Arm spread.",
      "openfda": {
        "device_name": "Mitral Valve Repair Devices",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
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