International safety notice
Technical Name: Heart Valve Prosthesis
Brazil / Anvisa · BRA · Aug 3, 2016
Key facts
| Title | Technical Name: Heart Valve Prosthesis |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: Transcatheter Aortic Valve Core Valve Evolut R // Technical Name: Heart Valve Prosthesis // ANVISA registration number: 10339190629 // Risk class: IV (Maximum Risk)// Model(s) affected and Lot(s)/Serial No.(s) affected. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO NOME MEDTRONIC COMERCIAL LTDA CNPJ 01772798000152 ENDEREÇO AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR CEP 04675010 MUNICÍPIO SÃO PAULO UF SP TELEFONE DE CONTATO 11 21829200 |
| Models | 10339190629 |
| Date | Aug 3, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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