PMA P900023S020

Device: ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S020
Product code: DSQ
Decision date: 1996-12-31
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR CHANGING THE TUBING DIAMETER OF THE TUBES LEADING TO/FROM THE LEFT SIDE FLOW TRANSDUCER FROM 1/4 INCH TO 1/16 INCH ID (INNDER DIAMETER) AND CHANGING THE CONSOLE COOLING FAN FROM ONE HAVING A CAPACITY OF 94 CFM (CUBIC FEET PER MINUTE) TO ONE HAVING A CAPACITY OF 55 CFM.

Current openFDA PMA Record#

Device: ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S020
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1996-12-31
Decision code: APPR
Date received: 1996-12-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGING THE TUBING DIAMETER OF THE TUBES LEADING TO/FROM THE LEFT SIDE FLOW TRANSDUCER FROM 1/4 INCH TO 1/16 INCH ID (INNDER DIAMETER) AND CHANGING THE CONSOLE COOLING FAN FROM ONE HAVING A CAPACITY OF 94 CFM (CUBIC FEET PER MINUTE) TO ONE HAVING A CAPACITY OF 55 CFM.