PMA P140003S103

Device: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S103
Product code: OZD
Decision date: 2022-08-31
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: Change to the bonding process between the pressure reservoir and check valve components in 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
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S103
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2022-08-31
Decision code: OK30
Date received: 2022-08-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the bonding process between the pressure reservoir and check valve components in the pressure storage set assembly.