{
  "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": "2026-07-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 316
    }
  },
  "results": [
    {
      "pma_number": "P050052",
      "supplement_number": "S084",
      "applicant": "Merz North America, Inc.",
      "street_1": "4133 Ct.ney Rd., Suite 10",
      "street_2": "",
      "city": "Franksville",
      "state": "WI",
      "zip": "53126",
      "zip_ext": "",
      "generic_name": "Implant, dermal, for aesthetic use",
      "trade_name": "RADIESSE Injectable Implant; RADIESSE (+) Lidocaine Dermal Filler",
      "product_code": "LMH",
      "advisory_committee": "SU",
      "advisory_committee_description": "General, Plastic Surgery",
      "supplement_type": "135 Review Track For 30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2016-05-31",
      "decision_date": "2016-10-26",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Manufacturing process changes to the final product syringe filling process.",
      "openfda": {
        "registration_number": [
          "",
          "3042708459",
          "3005113652",
          "3015471896",
          "3009882464",
          "3031056804",
          "3013840437",
          "3007093114",
          "3002807108",
          "2135225",
          "3007744205",
          "3036164410",
          "3027345797",
          "3002806738",
          "3004423487",
          "3005975625",
          "3026391021",
          "3007772056",
          "3015373820",
          "3043624366",
          "1000118068",
          "9710154",
          "3022121566",
          "3045078914",
          "2011068",
          "3006123332",
          "3043045982",
          "3003672980",
          "3031983053",
          "3033486016",
          "3010164402",
          "3006999111",
          "3004362706",
          "3037006441",
          "3003707320",
          "3019585045"
        ],
        "fei_number": [
          "",
          "3003347293",
          "3042708459",
          "3005113652",
          "3015471896",
          "3009882464",
          "3031056804",
          "3013840437",
          "3007517952",
          "3007093114",
          "3002807108",
          "3007744205",
          "3036164410",
          "3027345797",
          "3002806738",
          "3004423487",
          "3005975625",
          "3026391021",
          "3007772056",
          "3015373820",
          "3043624366",
          "1000118068",
          "2011068",
          "3022121566",
          "3045078914",
          "3003407669",
          "3006123332",
          "3043045982",
          "3003672980",
          "3031983053",
          "3033486016",
          "3006999111",
          "3037006441",
          "3004362706",
          "3003707320",
          "3019585045"
        ],
        "device_name": "Implant, Dermal, For Aesthetic Use",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}