PMA P140003S113

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: S113
Product code: OZD
Decision date: 2023-06-14
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: Approval to update the Instructions for Use of Impella Ventricular Support Systems to include a warning and recommendations when using Impella catheters with Transcatheter Aortic Valve Replacement (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: S113
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2023-06-14
Decision code: APPR
Date received: 2023-05-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to update the Instructions for Use of Impella Ventricular Support Systems to include a warning and recommendations when using Impella catheters with Transcatheter Aortic Valve Replacement (TAVR) devices.