{
  "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": 1
    }
  },
  "results": [
    {
      "pma_number": "P130013",
      "supplement_number": "",
      "applicant": "Boston Scientific Corp",
      "street_1": "One Scimed Pl.",
      "street_2": "",
      "city": "Maple Grove",
      "state": "MN",
      "zip": "55311",
      "zip_ext": "",
      "generic_name": "System, appendage closure, left atrial",
      "trade_name": "WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY",
      "product_code": "NGV",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "Y",
      "date_received": "2013-05-14",
      "decision_date": "2015-03-13",
      "docket_number": "15M-0910",
      "fed_reg_notice_date": "2015-03-13",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE WATCHMAN LAA CLOSURE TECHNOLOGY. THIS DEVICE IS INDICATED TO REDUCE THE RISK OF THROMBOEMBOLISM FROM THE LEFT ATRIAL APPENDAGE (LAA) IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION WHO: ARE AT INCREASED RISK FOR STROKE AND SYSTEMIC EMBOLISM BASED ON CHADS2 OR CHA2DS2-VASC SCORES AND ARE RECOMMENDED FOR ANTICOAGULATION THERAPY;  ARE DEEMED BY THEIR PHYSICIANS TO BE SUITABLE FOR WARFARIN; AND HAVE AN APPROPRIATE RATIONALE TO SEEK A NON-PHARMACOLOGIC ALTERNATIVE TO WARFARIN, TAKING INTO ACCOUNT THE SAFETY AND EFFECTIVENESS OF THE DEVICE COMPARED TO WARFARIN.",
      "openfda": {
        "registration_number": [
          "9681260",
          "2124215",
          "3005012805",
          "3010273872",
          "1721676",
          "1928237",
          "2134265",
          "1000121056",
          "3012179728",
          "2135147",
          "3010220595",
          "3005334138",
          "3002807314",
          "3014918977",
          "2183744",
          "3007113487",
          "1225687"
        ],
        "fei_number": [
          "2124215",
          "3005012805",
          "3010273872",
          "1721676",
          "3002806565",
          "1928237",
          "1000121056",
          "3012179728",
          "3010220595",
          "3002095335",
          "3005334138",
          "3002807314",
          "3014918977",
          "2183744",
          "3007113487",
          "3001451463"
        ],
        "device_name": "System, Appendage Closure, Left Atrial",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}