PMA P140003S116

Device: Impella CP, Impella CP with SmartAssist, Impella 2.5, Impella 5.0/LD, Impella 5.5 with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S116
Product code: OZD
Decision date: 2024-01-05
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: Approval for the addition of a warning statement related to ethylene oxide residuals to the Impella systems instructions for use.

Current openFDA PMA Record#

Device: Impella CP, Impella CP with SmartAssist, Impella 2.5, Impella 5.0/LD, Impella 5.5 with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S116
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2024-01-05
Decision code: APPR
Date received: 2023-12-08
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of a warning statement related to ethylene oxide residuals to the Impella systems instructions for use.