PMA P140003S107

Device: Impella Ventricular Support Systems
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S107
Product code: OZD
Decision date: 2023-03-29
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: Approval for various modifications to the Instructions for Use to add the final results of the Post-Approval Study (PAS) protocol.

Current openFDA PMA Record#

Device: Impella Ventricular Support Systems
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S107
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2023-03-29
Decision code: APPR
Date received: 2022-10-14
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for various modifications to the Instructions for Use to add the final results of the Post-Approval Study (PAS) protocol.