PMA P140003S128

Device: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S128
Product code: OZD
Decision date: 2025-07-25
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: a change to the component bonding process used for the pressure storage set assembly

Current openFDA PMA Record#

Device: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S128
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2025-07-25
Decision code: OK30
Date received: 2025-06-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to the component bonding process used for the pressure storage set assembly