{
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    "terms": "https://open.fda.gov/terms/",
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    "last_updated": "2026-10-12",
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      "applicant": "Biosense Webster, Inc.",
      "street_1": "31 Technology Dr., Suite 200",
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      "city": "Irvine",
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      "date_received": "2022-12-19",
      "decision_date": "2023-08-03",
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      "decision_code": "APPR",
      "ao_statement": "Approval for changes to the Instructions for Use (IFU) for the THERMOCOOL SMARTTOUCH® and SMARTTOUCH® SF Catheters that allow for the use of direct imaging guidance, such as fluoroscopy or ultrasound, during catheter manipulation; the changes are being made based on clinical data from the REAL AF Registry Sub-Study.",
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