PMA P140003S095

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: S095
Product code: OZD
Decision date: 2022-03-08
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: Replace a discontinued model of the electrical safety analyzer with a newer model for the final functional testing of the Automated Impella Controller.

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: S095
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2022-03-08
Decision code: OK30
Date received: 2022-02-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replace a discontinued model of the electrical safety analyzer with a newer model for the final functional testing of the Automated Impella Controller.