PMA P140003S135

Device: Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5 with Smart A
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S135
Product code: OZD
Decision date: 2026-02-06
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: approval for a modification to the Instructions for Use to allow sodium bicarbonate to be used in the purge fluid for the Impella catheters if heparin should not be used per the physician’s clinical judgement.

Current openFDA PMA Record#

Device: Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5 with Smart A
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S135
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2026-02-06
Decision code: APPR
Date received: 2025-10-23
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a modification to the Instructions for Use to allow sodium bicarbonate to be used in the purge fluid for the Impella catheters if heparin should not be used per the physician’s clinical judgement.