PMA P920014S007
- Device
- HEARTMATE(R) VE LVAS
- Applicant
- THORATEC CORP.
- PMA number
- P920014
- Supplement
- S007
- Product code
- DSQ
- Decision date
- 1998-09-29
- Generic name
- Ventricular (assist) Bypass
- Approval order statement
- Approval For The HeartMate(R) VE LVAS. This Device Is Indicated For Use As A Bridge To Transplantation In Cardiac Transplant Candidates At Risk Of Imminent Death From Nonreversible Left Ventricular Failure. The HeartMate(R) VE LVAS Is Indicated For Use Both Inside And Outside The Hospital.
- Summary
- Summary of Safety and Effectiveness
Current openFDA PMA Record
- Device
- HEARTMATE(R) VE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S007
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1998-09-29
- Decision code
- APPR
- Date received
- 1997-07-02
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the HeartMate(R) VE LVAS. This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The HeartMate(R) VE LVAS is indicated for use both inside and outside the hospital.