PMA P900023S040

Device: ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S040
Product code: DSQ
Decision date: 2004-06-28
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR THE ADDITION OF TWO INFLOW CANNULAE (MALLEABLE 42 FR. AND 32 FR.) TO BE ADDED TO THE CURRENTLY APPROVED CANNULAE USED WITH THE BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND THE AB5000 CIRCULATORY SUPPORT SYSTEM.

Current openFDA PMA Record#

Device: ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S040
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2004-06-28
Decision code: APPR
Date received: 2004-03-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF TWO INFLOW CANNULAE (MALLEABLE 42 FR. AND 32 FR.) TO BE ADDED TO THE CURRENTLY APPROVED CANNULAE USED WITH THE BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND THE AB5000 CIRCULATORY SUPPORT SYSTEM.