{
  "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": "2026-04-13",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Minnetonka",
      "advisory_committee_description": "Obstetrics/Gynecology",
      "address_1": "10700 Bren Rd. W.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "OTP",
      "openfda": {
        "registration_number": [
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          "2529647",
          "3004838863",
          "3006621295",
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          "3004838863",
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          "3006621295",
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        "device_name": "Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.5980",
        "device_class": "3"
      },
      "zip_code": "55343",
      "applicant": "American Medical Systems",
      "decision_date": "2011-07-01",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE",
      "advisory_committee": "OB",
      "contact": "MONA  INMAN",
      "expedited_review_flag": "",
      "k_number": "K111118",
      "state": "MN",
      "date_received": "2011-04-21",
      "review_advisory_committee": "OB",
      "postal_code": "55343",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
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}