PMA P920014S022
- Device
- THORATEC HEARTMATE XVE AND VE LEST VENTRICULAR ASSIST SYSTEM (LVAS)
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S022
- Product code
- DSQ
- Decision date
- 2003-12-02
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A MODIFIED STROKE VOLUME LIMITER DESIGN FOR THE HEARTMATE XVE AND SNAP-VE DEVICES.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE XVE AND VE LEST VENTRICULAR ASSIST SYSTEM (LVAS)
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S022
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2003-12-02
- Decision code
- APPR
- Date received
- 2003-06-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFIED STROKE VOLUME LIMITER DESIGN FOR THE HEARTMATE XVE AND SNAP-VE DEVICES.