{
  "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": {
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  "results": [
    {
      "pma_number": "P100009",
      "supplement_number": "S028",
      "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 Clip Delivery System and MitraClip NTR/XTR Clip Delivery System",
      "product_code": "NKM",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Panel Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2018-11-06",
      "decision_date": "2019-03-14",
      "docket_number": "19M-1251",
      "fed_reg_notice_date": "2019-03-19",
      "decision_code": "APPR",
      "ao_statement": "Approval for the MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System for expanding the indication to include secondary mitral regurgitation. The devices, when used with maximally tolerated guideline-directed medical therapy (GDMT), are indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR >= Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) >= 20% and <= 50%, and a left ventricular end systolic dimension (LVESD) <= 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.",
      "openfda": {
        "device_name": "Mitral Valve Repair Devices",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
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