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int32
0
900k
tokens
sequence
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sequence
900,100
[ "Commitments", "and", "Contingencies", "FDA", "Warning", "Letter", "On", "December", "29", ",", "2015", ",", "the", "FDA", "issued", "a", "Warning", "Letter", "alleging", "certain", "violations", "of", "FDA", "regulations", "applicable", "to", "medical", "device", "manufacturers", "at", "our", "Munich", ",", "Germany", "and", "Arvada", ",", "Colorado", "facilities", "." ]
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900,101
[ "The", "FDA", "inspected", "the", "Munich", "facility", "from", "August", "24", ",", "2015", "to", "August", "27", ",", "2015", "and", "the", "Arvada", "facility", "from", "August", "24", ",", "2015", "to", "September", "1", ",", "2015", "." ]
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900,102
[ "On", "August", "27", ",", "2015", ",", "the", "FDA", "issued", "a", "Form", "483", "identifying", "two", "observed", "non", "-", "conformities", "with", "certain", "regulatory", "requirements", "at", "the", "Munich", "facility", "." ]
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900,103
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900,104
[ "Following", "the", "receipt", "of", "the", "Form", "483", ",", "we", "provided", "written", "responses", "to", "the", "FDA", "describing", "corrective", "and", "preventive", "actions", "that", "were", "underway", "or", "to", "be", "taken", "to", "address", "the", "FDA", "’", "s", "observations", "at", "the", "Munich", "facility", "." ]
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900,105
[ "The", "Warning", "Letter", "responded", "in", "part", "to", "our", "responses", "and", "identified", "other", "alleged", "violations", "related", "to", "the", "manufacture", "of", "our", "3", "T", "Heater", "-", "Cooler", "device", "that", "were", "not", "previously", "included", "in", "the", "Form", "483", "." ]
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900,106
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900,107
[ "To", "help", "clarify", "these", "issues", "for", "current", "customers", ",", "we", "issued", "an", "informational", "Customer", "Letter", "in", "January", "2016", "and", "that", "same", "month", "agreed", "with", "the", "FDA", "on", "a", "process", "for", "shipping", "3", "T", "devices", "to", "existing", "U.S.", "users", "pursuant", "to", "a", "certificate", "of", "medical", "necessity", "program", "." ]
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900,108
[ "On", "February", "25", ",", "2020", ",", "Liva", "Nova", "received", "clearance", "for", "K191402", ",", "a", "510", "(", "k", ")", "for", "the", "3", "T", "devices", "that", "addressed", "issues", "contained", "in", "the", "2015", "Warning", "Letter", "along", "with", "design", "changes", "that", "further", "mitigate", "the", "potential", "risk", "of", "aerosolization", "." ]
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900,109
[ "Concurrent", "with", "this", "clearance", ",", "(", "1", ")", "3", "T", "devices", "manufactured", "in", "accordance", "with", "K191402", "will", "not", "be", "subjected", "to", "the", "import", "alert", "and", "(", "2", ")", "Liva", "Nova", "initiated", "a", "correction", "to", "distribute", "the", "updated", "Operating", "Instructions", "cleared", "under", "K191402", ".", "We", "continue", "to", "work", "diligently", "to", "remediate", "the", "FDA", "’", "s", "inspectional", "observations", "for", "the", "Munich", "facility", ",", "as", "well", "as", "the", "additional", "issues", "identified", "in", "the", "Warning", "Letter", "." ]
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900,110
[ "19", "CDC", "and", "FDA", "Safety", "Communications", "and", "Company", "Field", "Safety", "Notice", "On", "October", "13", ",", "2016", ",", "the", "CDC", "and", "the", "FDA", "separately", "released", "safety", "notifications", "regarding", "the", "3", "T", "devices", "." ]
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900,111
[ "Citing", "the", "geographic", "separation", "between", "the", "two", "hospitals", "referenced", "in", "the", "investigation", ",", "the", "report", "asserts", "that", "3", "T", "devices", "manufactured", "prior", "to", "August", "18", ",", "2014", "could", "have", "been", "contaminated", "during", "the", "manufacturing", "process", "." ]
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900,112
[ "Also", "on", "October", "13", ",", "2016", ",", "concurrent", "with", "the", "CDC", "’", "s", "HAN", "and", "FDA", "’", "s", "Safety", "Communication", ",", "we", "issued", "a", "Field", "Safety", "Notice", "Update", "for", "U.S.", "users", "of", "3", "T", "devices", "to", "proactively", "and", "voluntarily", "contact", "facilities", "to", "aid", "in", "implementation", "of", "the", "CDC", "and", "FDA", "recommendations", "." ]
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900,113
[ "In", "the", "fourth", "quarter", "of", "2016", ",", "we", "initiated", "a", "program", "to", "provide", "existing", "3", "T", "device", "users", "with", "a", "new", "loaner", "3", "T", "device", "at", "no", "charge", "pending", "regulatory", "approval", "and", "implementation", "of", "additional", "risk", "mitigation", "strategies", "worldwide", ",", "including", "a", "vacuum", "canister", "and", "internal", "sealing", "upgrade", "program", "and", "a", "deep", "disinfection", "service", "." ]
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900,114
[ "On", "October", "11", ",", "2018", ",", "after", "review", "of", "information", "provided", "by", "us", ",", "the", "FDA", "concluded", "that", "we", "could", "commence", "the", "vacuum", "and", "sealing", "upgrade", "program", "in", "the", "U.S.", ",", "and", "on", "February", "25", ",", "2020", ",", "Liva", "Nova", "received", "clearance", "for", "K191402", ",", "a", "510", "(", "k", ")", "for", "the", "3", "T", "devices", "that", "addressed", "issues", "contained", "in", "the", "2015", "Warning", "Letter", "along", "with", "design", "changes", "that", "further", "mitigate", "the", "potential", "risk", "of", "aerosolization", "." ]
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900,115
[ "The", "deep", "disinfection", "service", "was", "rolled", "out", "in", "Europe", "in", "the", "second", "half", "of", "2015", ",", "and", "on", "April", "12", ",", "2018", ",", "the", "FDA", "agreed", "to", "allow", "us", "to", "move", "forward", "with", "the", "deep", "cleaning", "service", "in", "the", "U.S.", "thereby", "adding", "to", "the", "growing", "list", "of", "countries", "around", "the", "world", "in", "which", "we", "offer", "this", "service", "." ]
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900,116
[ "On", "December", "31", ",", "2016", ",", "we", "recognized", "a", "liability", "for", "our", "product", "remediation", "plan", "related", "to", "our", "3", "T", "device", "." ]
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900,117
[ "We", "concluded", "that", "it", "was", "probable", "that", "a", "liability", "had", "been", "incurred", "upon", "management", "’", "s", "approval", "of", "the", "plan", "and", "the", "commitments", "made", "by", "management", "to", "various", "regulatory", "authorities", "globally", "in", "November", "and", "December", "2016", ",", "and", "furthermore", ",", "the", "cost", "associated", "with", "the", "plan", "was", "reasonably", "estimable", "." ]
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900,118
[ "At", "March", "31", ",", "2020", ",", "the", "product", "remediation", "liability", "was", "$", "1.6", "million", "." ]
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900,119
[ "The", "class", "action", ",", "filed", "in", "February", "2016", ",", "consists", "of", "all", "Pennsylvania", "residents", "who", "underwent", "open", "heart", "surgery", "at", "Well", "Span", "York", "Hospital", "and", "Penn", "State", "Milton", "S.", "Hershey", "Medical", "Center", "between", "2011", "and", "2015", "and", "who", "currently", "are", "asymptomatic", "for", "NTM", "infection", "." ]
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900,120
[ "On", "March", "29", ",", "2019", ",", "we", "announced", "a", "settlement", "framework", "that", "provides", "for", "a", "comprehensive", "resolution", "of", "the", "personal", "injury", "cases", "pending", "in", "the", "multi", "-", "district", "litigation", "in", "U.S.", "federal", "court", ",", "the", "related", "class", "action", "pending", "in", "federal", "court", ",", "as", "well", "as", "certain", "cases", "in", "state", "courts", "across", "the", "United", "States", "." ]
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900,121
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900,122
[ "At", "March", "31", ",", "2020", ",", "the", "provision", "for", "these", "matters", "was", "$", "54.6", "million", "." ]
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900,123
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900,124
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900,125
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900,126
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900,127
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900,128
[ "The", "Public", "Administrations", "appealed", "the", "2016", "Decision", "to", "the", "Court", "of", "Appeal", "of", "Milan", "." ]
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900,129
[ "On", "March", "5", ",", "2019", ",", "the", "Court", "of", "Appeal", "issued", "a", "partial", "decision", "on", "the", "merits", "declaring", "Sorin", "/", "Liva", "Nova", "jointly", "liable", "with", "SNIA", "for", "SNIA", "’", "s", "environmental", "liabilities", "in", "an", "amount", "up", "to", "the", "fair", "value", "of", "the", "net", "worth", "received", "by", "Sorin", "because", "of", "the", "Sorin", "spin", "-", "off", ",", "an", "estimated", "€", "572.1", "million", "(", "approximately", "$", "626.8", "million", "as", "of", "March", "31", ",", "2020", ")", "." ]
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900,130
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