PMA P920014S021
- Device
- THORATEC HEARTMATE XVE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S021
- Product code
- DSQ
- Decision date
- 2003-10-31
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR THE USE OF A NEW INFLOW VALVE ASSEMBLY DESIGN FOR THE THORATEC HEARTMATE XVE LVAS.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE XVE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S021
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2003-10-31
- Decision code
- APPR
- Date received
- 2003-04-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF A NEW INFLOW VALVE ASSEMBLY DESIGN FOR THE THORATEC HEARTMATE XVE LVAS.