International safety notice

Technical name: Heart Valve Prosthesis

Brazil / Anvisa · BRA · Feb 23, 2017

Key facts

Title Technical name: Heart Valve Prosthesis
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: LOTUS VALVE SYSTEM Technical name: Heart Valve Prosthesis ANVISA registration number: 10341350785 Risk class: IV Affected model: H749LTV230;H749LTV270;H749LTV250
Manufacturer EMPRESA DETENTORA DO REGISTRO BOSTON SCIENTIFIC DO BRASIL LTDA CNPJ 01513946000114 ENDEREÇO AV DAS NAÇÕES UNIDAS 21476 EDIFÍCIOS P8 P9 E P10 VILA ALMEIDA TELEFONE 11 43808706 FABRICANTE BOSTON SCIENTIFIC LIMITED ENDEREÇO BALLYBRIT BUSINESS PARK IRLANDA
Models H749LTV230, 10341350785, H749LTV270, H749LTV250
Date Feb 23, 2017
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data
  • 1–9 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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