PMA P900023S037

Device: ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S037
Product code: DSQ
Decision date: 2003-04-28
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR THE ADDITION OF THE AB5000 PNEUMATIC DRIVE CONSOLE TO THE BVS 5000 DEVICE SYSTEM. THE AB5000 CONSOLE CAN BE USED TO DRIVE ONE OR TWO BVS 5000 BLOOD PUMPS; IT CAN BE USED EITHER IN THE HOSPITAL OR FOR TRANSPORT OF PATIENTS BETWEEN HOSPITALS.

Current openFDA PMA Record#

Device: ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S037
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2003-04-28
Decision code: APPR
Date received: 2002-07-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF THE AB5000 PNEUMATIC DRIVE CONSOLE TO THE BVS 5000 DEVICE SYSTEM. THE AB5000 CONSOLE CAN BE USED TO DRIVE ONE OR TWO BVS 5000 BLOOD PUMPS; IT CAN BE USED EITHER IN THE HOSPITAL OR FOR TRANSPORT OF PATIENTS BETWEEN HOSPITALS.