PMA P140003S115

Device: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S115
Product code: OZD
Decision date: 2023-11-29
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: Approval for the IFU update of Impella Ventricular Support Systems to provide warning and potential adverse events associated with using Impella Left Ventricular Support catheters with TAVR devices.

Current openFDA PMA Record#

Device: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S115
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2023-11-29
Decision code: APPR
Date received: 2023-10-30
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the IFU update of Impella Ventricular Support Systems to provide warning and potential adverse events associated with using Impella Left Ventricular Support catheters with TAVR devices.