PMA P920014S017
- Device
- THORETEC HEARTMATE XVE LVAS
- Applicant
- THORATEC CORP.
- PMA number
- P920014
- Supplement
- S017
- Product code
- DSQ
- Decision date
- 2003-04-04
- Generic name
- Ventricular (assist) Bypass
- Approval order statement
- APPROVAL FOR AN EXPANDED INDICATION FOR USE FOR THE THORATEC HEARTMATE XVE LVAS. THIS DEVICE SYSTEM 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 THE HOSPITAL.
Current openFDA PMA Record
- Device
- THORETEC HEARTMATE XVE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S017
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2003-04-04
- Decision code
- APPR
- Date received
- 2002-11-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR AN EXPANDED INDICATION FOR USE FOR THE THORATEC HEARTMATE XVE LVAS. THIS DEVICE SYSTEM 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 THE HOSPITAL.