PMA P920014S016

Device: THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS)
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S016
Product code: DSQ
Decision date: 2002-11-06
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR AN EXPANDED INDICATION FOR USE FOR THE THORATEC HEARTMATE SNAP VE LVAS. THE DEVICE IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE. IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION CLASS IV END STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 60 OF THE LAST 90 DAYS, AND WHO HAVE A LIFE EXPECTANCY OF LESS THAN TWO YEARS, AND WHO ARE NOT ELIGIBLE FOR CARDIAC TRANSPLANTATION. THE DEVICE SYSTEM IS APPROVED FOR USE BOTH INSIDE AND OUTSIDE OF THE HOSPITAL.

Current openFDA PMA Record

Device: THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS)
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S016
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2002-11-06
Decision code: APPR
Date received: 2001-10-16
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR AN EXPANDED INDICATION FOR USE FOR THE THORATEC HEARTMATE SNAP VE LVAS. THE DEVICE IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE. IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION CLASS IV END STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 60 OF THE LAST 90 DAYS, AND WHO HAVE A LIFE EXPECTANCY OF LESS THAN TWO YEARS, AND WHO ARE NOT ELIGIBLE FOR CARDIAC TRANSPLANTATION. THE DEVICE SYSTEM IS APPROVED FOR USE BOTH INSIDE AND OUTSIDE OF THE HOSPITAL.