PMA P980012S005

Device: NOVACOR N100PCQ LVAS
Applicant: Worldheart, Inc.
PMA number: P980012
Supplement: S005
Product code: DSQ
Decision date: 2004-01-02
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR SEVERAL SPECIFIC ENGINEERING ENHANCEMENTS TO THE IMPLANTED (PUMP/DRIVE UNIT, BLOOD CONDUITS, AND PERCUTANEOUS LEAD) COMPONENTS OF THE NOVACOR N100PC LVAS SYSTEM AS WELL AS MODIFICATIONS TO THE SOFTWARE TO UPGRADE TO THE N100PCQ LVAS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NOVACOR N100PCQ LVAS SYSTEM AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FUNCTION FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL.

Current openFDA PMA Record

Device: NOVACOR N100PCQ LVAS
Applicant: Worldheart, Inc.
PMA number: P980012
Supplement: S005
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2004-01-02
Decision code: APPR
Date received: 2003-01-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR SEVERAL SPECIFIC ENGINEERING ENHANCEMENTS TO THE IMPLANTED (PUMP/DRIVE UNIT, BLOOD CONDUITS, AND PERCUTANEOUS LEAD) COMPONENTS OF THE NOVACOR N100PC LVAS SYSTEM AS WELL AS MODIFICATIONS TO THE SOFTWARE TO UPGRADE TO THE N100PCQ LVAS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NOVACOR N100PCQ LVAS SYSTEM AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FUNCTION FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL.