PMA P140003S110

Device: Impella 2.5, Impella CP and CP with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S110
Product code: OZD
Decision date: 2023-04-27
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: Approval of the revised protocol for the Impella Real-World Surveillance of patients using Sodium Bicarbonate. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval orders for P140003/S088 and P170011/S035.

Current openFDA PMA Record#

Device: Impella 2.5, Impella CP and CP with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S110
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2023-04-27
Decision code: APPR
Date received: 2023-03-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocol for the Impella Real-World Surveillance of patients using Sodium Bicarbonate. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval orders for P140003/S088 and P170011/S035.