{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "NKM",
      "openfda": {
        "pma_number": [
          "P100009",
          "P220003"
        ],
        "registration_number": [
          "3002807314",
          "2135147",
          "2939561",
          "2011171",
          "3019807891",
          "3009420598",
          "1721676",
          "3017298588",
          "3007113487",
          "3020950818",
          "3008500478",
          "3005941719",
          "3004091615",
          "3005102565",
          "3007063218",
          "2024311",
          "3015807001",
          "2015691",
          "3005070406"
        ],
        "fei_number": [
          "3004635528",
          "3002807314",
          "2011171",
          "3019807891",
          "3002807111",
          "3009420598",
          "1713910",
          "1721676",
          "3017298588",
          "3007113487",
          "3020950818",
          "3004091615",
          "3005102565",
          "3007063218",
          "3005334138",
          "2024311",
          "3015807001",
          "2015691",
          "3005070406"
        ]
      },
      "review_panel": "CV",
      "medical_specialty": "",
      "device_name": "Mitral Valve Repair Devices",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "3",
      "definition": "To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation.  These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.",
      "regulation_number": "",
      "implant_flag": "Y",
      "submission_type_id": "2"
    }
  ]
}