FDA.reportPublic FDA data

PMA P140003S066

Device
IMPELLA 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist System, and
Applicant
Abiomed, Inc.
PMA number
P140003
Supplement
S066
Product code
OZD
Decision date
2020-01-22
Generic name
Temporary non-roller type left heart support blood pump
Approval order statement
Approval for adding a caution to the Impella Instructions for Use label regarding continuing Impella therapy in cardiogenic shock patients where Extra-corporeal Membrane Oxygenation (ECMO) is to be initiated.

Current openFDA PMA Record#

Device
IMPELLA 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist System, and
Applicant
Abiomed, Inc.
PMA number
P140003
Supplement
S066
Product code
OZD
Generic name
Temporary non-roller type left heart support blood pump
Decision date
2020-01-22
Decision code
APPR
Date received
2019-12-23
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for adding a caution to the Impella Instructions for Use label regarding continuing Impella therapy in cardiogenic shock patients where Extra-corporeal Membrane Oxygenation (ECMO) is to be initiated.