{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Marborough",
      "advisory_committee_description": "General, Plastic Surgery",
      "address_1": "300 Boston Scientific Way",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "OTM",
      "openfda": {
        "device_name": "Mesh, Surgical, For Stress Urinary Incontinence, Male",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.3300",
        "device_class": "2",
        "registration_number": [
          "3006621295",
          "1828132",
          "1000121056",
          "2529647",
          "3017791709",
          "3005099803",
          "2124215",
          "3004838863",
          "1225687",
          "2183744",
          "2125050",
          "3010178296"
        ],
        "fei_number": [
          "3001451463",
          "3006621295",
          "1828132",
          "1000121056",
          "3017791709",
          "3005099803",
          "2124215",
          "3004838863",
          "2183744",
          "2125050",
          "1000121298",
          "3003110073"
        ]
      },
      "zip_code": "01752",
      "applicant": "Boston Scientific Corporation",
      "decision_date": "2021-12-20",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "AdVance XP Male Sling System",
      "advisory_committee": "SU",
      "contact": "Anuja  Bhatt",
      "expedited_review_flag": "",
      "k_number": "K211847",
      "state": "MA",
      "date_received": "2021-06-15",
      "review_advisory_committee": "GU",
      "postal_code": "01752",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}