{
  "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": "2026-10-12",
    "results": {
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      "supplement_number": "S001",
      "applicant": "Boston Scientific Corporation",
      "street_1": "4100 Hamline Ave. N",
      "street_2": "",
      "city": "St Paul",
      "state": "MN",
      "zip": "55112",
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      "trade_name": "POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories",
      "product_code": "OAE",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Postapproval Study Protocol",
      "expedited_review_flag": "N",
      "date_received": "2023-09-07",
      "decision_date": "2023-11-17",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220032. Based upon the information submitted, the PMA supplement is approved.",
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        "medical_specialty_description": "Unknown",
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    }
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}