PMA P900023S013

Device: ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S013
Product code: DSQ
Decision date: 1996-01-29
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR INCREASING THE LEFT SIDE FLOW CAPACITY OF THE ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM BY APPROXIMATELY 1 LITE/MINUTE (I.E., FROM 5 LITERS/MINUTE TO APPROXIMATELY 6 LITERS/MINUTE

Current openFDA PMA Record#

Device: ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S013
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1996-01-29
Decision code: APPR
Date received: 1994-08-31
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR INCREASING THE LEFT SIDE FLOW CAPACITY OF THE ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM BY APPROXIMATELY 1 LITE/MINUTE (I.E., FROM 5 LITERS/MINUTE TO APPROXIMATELY 6 LITERS/MINUTE