PMA P900023S043

Device: ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S043
Product code: DSQ
Decision date: 2005-03-11
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR THE ADDITION OF FOUR NEW INFLOW CANNULAE (32/42 FR APICAL CANNULA WITH SIDE HOLES AND 32/42 FR APICAL CANNULA WITHOUT SIDE HOLES) FOR USE 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: S043
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2005-03-11
Decision code: APPR
Date received: 2005-01-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF FOUR NEW INFLOW CANNULAE (32/42 FR APICAL CANNULA WITH SIDE HOLES AND 32/42 FR APICAL CANNULA WITHOUT SIDE HOLES) FOR USE WITH THE BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND THE AB5000 CIRCULATORY SUPPORT SYSTEM.