PMA P900023S044

Device: 42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S044
Product code: DSQ
Decision date: 2006-07-07
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR DESIGN CHANGES TO INTEGRATE THE PREVIOUSLY APPROVED 42 FR. VENTRICULAR/ATRIAL CANNULA AND PREVIOUSLY APPROVED SEWING CUFF ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 42 FR. VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF AND IS INDICATED FOR USE WITH THE BVS 5000 BIVENTRICULAR SUPPORT SYSTEM AND WITH THE AB5000 CIRCULATORY SUPPORT SYSTEM.

Current openFDA PMA Record#

Device: 42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S044
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2006-07-07
Decision code: APPR
Date received: 2006-01-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR DESIGN CHANGES TO INTEGRATE THE PREVIOUSLY APPROVED 42 FR. VENTRICULAR/ATRIAL CANNULA AND PREVIOUSLY APPROVED SEWING CUFF ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 42 FR. VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF AND IS INDICATED FOR USE WITH THE BVS 5000 BIVENTRICULAR SUPPORT SYSTEM AND WITH THE AB5000 CIRCULATORY SUPPORT SYSTEM.