PMA P060040S005
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S005
- Product code
- DSQ
- Decision date
- 2010-01-20
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR THE THORATEC HEARTMATE II LVAS. THE DEVICE IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NON-REVERSIBLE LEFT VENTRICULAR FAILURE. IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION (NYHA) CLASS IIIB OR IV END-STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 45 OF THE LAST 60 DAYS, AND ARE NOT CANDIDATES FOR CARDIAC TRANSPLANTATION. THE HEARTMATE II LVAS IS INTENDED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL, OR FOR TRANSPORTATION OF VENTRICULAR ASSIST DEVICE PATIENTS VIA GROUND AMBULANCE, FIXED-WING AIRCRAFT, OR HELICOPTER.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060040S005B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S005
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2010-01-20
- Decision code
- APPR
- Date received
- 2009-04-20
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE THORATEC HEARTMATE II LVAS. THE DEVICE IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NON-REVERSIBLE LEFT VENTRICULAR FAILURE. IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION (NYHA) CLASS IIIB OR IV END-STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 45 OF THE LAST 60 DAYS, AND ARE NOT CANDIDATES FOR CARDIAC TRANSPLANTATION. THE HEARTMATE II LVAS IS INTENDED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL, OR FOR TRANSPORTATION OF VENTRICULAR ASSIST DEVICE PATIENTS VIA GROUND AMBULANCE, FIXED-WING AIRCRAFT, OR HELICOPTER.