PMA P920014S024
- Device
- THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S024
- Product code
- DSQ
- Decision date
- 2005-02-02
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE EXISTING SYSTEM MONITOR DESIGN, WHICH IS USED WITH THE HEARTMATE XVE AND VE DEVICES.
Current openFDA PMA Record
- Device
- THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S024
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2005-02-02
- Decision code
- APPR
- Date received
- 2004-08-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE EXISTING SYSTEM MONITOR DESIGN, WHICH IS USED WITH THE HEARTMATE XVE AND VE DEVICES.