PMA P870072S045
- Device
- THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S045
- Product code
- DSQ
- Decision date
- 2010-11-05
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR INCREASING THE SERVICE INTERVAL FOR THE TLC-IIPLUS PORTABLE VAD DRIVER FROM 4500 HOURS TO 8000 HOURS.
Current openFDA PMA Record#
- Device
- THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S045
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2010-11-05
- Decision code
- APPR
- Date received
- 2010-09-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR INCREASING THE SERVICE INTERVAL FOR THE TLC-IIPLUS PORTABLE VAD DRIVER FROM 4500 HOURS TO 8000 HOURS.