PMA P140003S111

Device: Impella CP with SmartAssist, Impella 5.5 with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S111
Product code: OZD
Decision date: 2024-12-03
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: Approval for a labeling update regarding pediatric uses of the Impella CP with SmartAssist and Impella 5.5 with SmartAssist systems.

Current openFDA PMA Record#

Device: Impella CP with SmartAssist, Impella 5.5 with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S111
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2024-12-03
Decision code: APPR
Date received: 2023-03-31
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a labeling update regarding pediatric uses of the Impella CP with SmartAssist and Impella 5.5 with SmartAssist systems.