Ventricular (Assist) Bypass
Basic Information
- Device Name
- Ventricular (Assist) Bypass
- Trade Name
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- PMA Number
- P060040
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- DSQ
- Generic Name
- Ventricular (assist) bypass
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 20, 2010
- Date Received
- April 20, 2009
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 10M-0078
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSQ | Ventricular (Assist) Bypass | FDA class 3 | Unknown |