{
  "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": "2026-10-19",
    "results": {
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  "results": [
    {
      "pma_number": "P190002",
      "supplement_number": "S014",
      "applicant": "Saluda Medical Pty, Ltd.",
      "street_1": "Level 1, 407 Pacific Hwy.",
      "street_2": "",
      "city": "Atarmon",
      "state": "",
      "zip": "NSW 2064",
      "zip_ext": "",
      "generic_name": "Stimulator, spinal-cord, totally implanted for pain relief",
      "trade_name": "Saluda Medical Evoke® SCS System",
      "product_code": "LGW",
      "advisory_committee": "NE",
      "advisory_committee_description": "Neurology",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2022-09-30",
      "decision_date": "2023-09-22",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for a labeling change to the following implantable components of the Saluda Evoke Spinal Cord Stimulation (SCS) System as Magnetic Resonance (MR) Conditional for head and extremities (1.5 or 3.0 T) and full body (1.5 T):1)  Evoke Closed Loop Stimulator Kit;2)  Evoke CAP12 Percutaneous Leads Kit – 60/90cm;3)  Evoke 12C Percutaneous Leads Kit – 60/90cm;4)  Evoke Spares Kit;5)  Evoke Active Anchor Kit; and6)  Evoke CAP12X Lead Extension Kit – 55cm.",
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        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
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    }
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}