PMA P870072S037
- Device
- THORATEC TLC-II PORTABLE VAD DRIVER
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S037
- Product code
- DSQ
- Decision date
- 2007-11-14
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR REDUCING THE MAINTENANCE SERVICE INTERVAL FOR THE TLC II PORTABLE VAD DRIVER TO 1500 HOURS FROM THE CURRENT 3000 HOUR INTERVAL.
Current openFDA PMA Record#
- Device
- THORATEC TLC-II PORTABLE VAD DRIVER
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S037
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2007-11-14
- Decision code
- APPR
- Date received
- 2007-07-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REDUCING THE MAINTENANCE SERVICE INTERVAL FOR THE TLC II PORTABLE VAD DRIVER TO 1500 HOURS FROM THE CURRENT 3000 HOUR INTERVAL.