Abiomed, Inc.
66 FDA actions
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Abiomed, Inc.
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with correspon
Abiomed, Inc.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Co
Abiomed, Inc.
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Abiomed, Inc.
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller
Abiomed, Inc.
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurat
Abiomed, Inc.
Impella RP Flex with SmartAssist. Product Code: 1000323.
Abiomed, Inc.
Impella RP with SmartAssist. Product Code: 0046-0035.
Abiomed, Inc.
Impella RP. Product Code: 0046-0011.
Abiomed, Inc.
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Abiomed, Inc.
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect
Abiomed, Inc.
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding
Abiomed, Inc.
14Fr Low Profile Introducer Kit
Abiomed, Inc.
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Co
Abiomed, Inc.
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Contr
Abiomed, Inc.
Impella RP Flex with SmartAssist; Product Number: 1000323;
Abiomed, Inc.
Impella RP with SmartAssist; Product Number: 0046-0035;
Abiomed, Inc.
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Abiomed, Inc.
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Abiomed, Inc.
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Abiomed, Inc.
Pump 381 Pump Set (US); Product Code: 1000080;
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Abiomed, Inc.
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Abiomed, Inc.
Impella CP Smart Assist Set; Product Code: 1000402;
Abiomed, Inc.
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Abiomed, Inc.
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
Abiomed, Inc.
Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
Abiomed, Inc.
Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
Abiomed, Inc.
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
Abiomed, Inc.
Pump 371 14F LT CMR Set; Product Code: 0048-0045;
Abiomed, Inc.
Impella 5.5 Set AU; Product Code: 1000361;
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
Abiomed, Inc.
Abiomed 14Fr Low Profile Introducer Kit
Abiomed, Inc.
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Abiomed, Inc.
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular
Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code
Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Cod
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are inte
Abiomed, Inc.
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Imp
Abiomed, Inc.
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the
Abiomed, Inc.
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Imp
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the
Abiomed, Inc.
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Ca
Abiomed, Inc.
Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of th
Abiomed, Inc.
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part
Abiomed, Inc.
Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for i
Abiomed, Inc.
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remote
Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Abiomed, Inc.
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Abiomed, Inc.
Impella LD intravascular micro axial blood pump, Product Number 005082
Abiomed, Inc.
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Abiomed, Inc.
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
Abiomed, Inc.
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
Abiomed, Inc.
Impella CP intravascular micro axial blood pump, Product Number 0048-0032
Abiomed, Inc.
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Abiomed, Inc.
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Abiomed, Inc.
preCARDIA Occlusion System
Abiomed, Inc.
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory s
Abiomed, Inc.
OXY-1 System
Abiomed, Inc.
Abiomed 14Fr Low Profile Introducer Set
Abiomed, Inc.
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pum
Abiomed, Inc.