FDA.reportPublic FDA data

PMA P140003S117

Device
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist Systems
Applicant
Abiomed, Inc.
PMA number
P140003
Supplement
S117
Product code
OZD
Decision date
2023-12-21
Classification
Cardiovascular
Generic name
Temporary non-roller type left heart support blood pump
Approval order statement
approval for changes to the device labeling for the continued safe use of Impella catheters in regard to ventricular perforation and cotton fiber ingestion.

Current openFDA PMA Record#

Device
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist Systems
Applicant
Abiomed, Inc.
PMA number
P140003
Supplement
S117
Product code
OZD
Generic name
Temporary non-roller type left heart support blood pump
Decision date
2023-12-21
Decision code
APPR
Date received
2023-12-18
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
approval for changes to the device labeling for the continued safe use of Impella catheters in regard to ventricular perforation and cotton fiber ingestion.