HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA premarket approval P100047 · decided 2012-11-20
Approval details
- PMA number
- P100047
- Trade name
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2010-12-28
- Decision date
- 2012-11-20
- Days to decision
- 693 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE HEARTWARE VENTRICULAR ASSIST SYSTEM (VAS). THIS DEVICE IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE HEART WARE VAS IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS, INCLUDING TRANSPORTATION VIA FIXED WING AIRCRAFT OR HELICOPTER.
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