{
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-19",
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      "pma_number": "P080003",
      "supplement_number": "S008",
      "applicant": "Hologic, Inc.",
      "street_1": "35 Crosby Dr.",
      "street_2": "",
      "city": "Bedford",
      "state": "MA",
      "zip": "01730",
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      "generic_name": "Digital breast tomosynthesis",
      "trade_name": "Selenia Dimensions 3D System High Resolution Tomosynthesis",
      "product_code": "OTE",
      "advisory_committee": "RA",
      "advisory_committee_description": "Radiology",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2019-04-04",
      "decision_date": "2019-10-24",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for software option 3DQuoromTM technology, which generates thicker 6 mm slices (also referred as SmartSlices or slabs) and change to the indications for use statement as a result of this update.",
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