OZD · Temporary Non-Roller Type Left Heart Support Blood Pump

· Class 3

Overview

Product CodeOZD
Device NameTemporary Non-Roller Type Left Heart Support Blood Pump
Device ClassClass 3
Review Panel
Life-SustainingYes

Identification

A blood pump that provides temporary full or partial left heart support

Recent Cleared Devices (4 of 4)

RecordDevice NameApplicantDecision DateDecision
P140003S018Impella Ventricular Support SystemsAbiomed, Inc.Feb 7, 2018APPR
P140003S005IMPELLA LEFT VENTRICULAR SUPPORT SYSTEMAbiomed, Inc.Apr 7, 2016APPR
P140003S004IMPELLA VENTRICULAR SUPPORT SYSTEMSAbiomed, Inc.Apr 7, 2016APPR
P140003IMPELLA 2.5 SystemAbiomed, Inc.Mar 23, 2015APPR

Top Applicants

Innolitics

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