PMA P900023S042

Device: ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S042
Product code: DSQ
Decision date: 2005-03-23
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR A CHANGE TO ONLY THE AB5000 CIRCULATORY SUPPORT SYSTEM THAT WILL ALLOW THE USER AN ALTERNATE MEANS OF REDUCING BLOOD FLOW DURING WEANING BY ADJUSTING THE LEVEL OF VACUUM APPLIED TO THE AB5000 BLOOD PUMP.

Current openFDA PMA Record#

Device: ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S042
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2005-03-23
Decision code: APPR
Date received: 2004-12-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO ONLY THE AB5000 CIRCULATORY SUPPORT SYSTEM THAT WILL ALLOW THE USER AN ALTERNATE MEANS OF REDUCING BLOOD FLOW DURING WEANING BY ADJUSTING THE LEVEL OF VACUUM APPLIED TO THE AB5000 BLOOD PUMP.