HeartWare HVAD System

Device name

HeartWare HVAD System

Model / reference

MCS1708TW

Primary DI / UDI-DI

00763000943202

Basic UDI-DI

0763000B000092489

EMDN code

J01030102 Implantable left monoventricular assistance systems (lvad)

Device class

Class III

EU registration type

Standard device

EU market of registration

Netherlands

EUDAMED SRN

US-MF-000019976

Authorised representative

Medtronic B.V. NL-AR-000006050

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• HeartWare HVAD System

  Class III

  CE/MDR

• HeartWare™ Battery 1650 Open recall

  Class III

  CE/MDR MDR 737528 Active Valid to Aug 2029 FDA PMA P100047 Active Approved 20 Nov 2012 +1authorizations

• HeartWare™ Waist Pack 2050 Open recall

  Class III

  CE/MDR MDR 737528 Active Valid to Aug 2029 FDA PMA P100047 Active Approved 20 Nov 2012 +1authorizations

• HeartWare™ Shoulder Pack 2060 Open recall

  Class III

  CE/MDR MDR 737528 Active Valid to Aug 2029 FDA PMA P100047 Active Approved 20 Nov 2012 +1authorizations

See all devices from Heartware Inc. →