Certificates, Approvals & Clinical Studies

The HeartAssist 5® Pediatric VAD is the only FDA approved Pediatric VAD in the United States.

HeartAssist 5® Pediatric VAD

- FDA Pediatric VAD Approval Letter
- HDE Application Supplement - Name Change
- Pediatric Directions for Use
- Summary of Safety and Probable Benefit

DeBakey VAD® for Adults

- FDA Performance Goal Clinical Study

Manufacturing Facility - ISO 13485:2003 Certificate

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The HeartAssist 5™ Pediatric VAD is authorized by Federal law for use in providing temporary mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients 5-16 years old who are listed for transplant. The effectiveness of this device for this use has not been demonstrated.