PMA P870072S043
- Device
- TLC-2PLUS PORTABLE VAD DRIVER
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S043
- Product code
- DSQ
- Decision date
- 2010-03-30
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A FIRMWARE MODIFICATION TO THE OCCLUSION ALARM ALGORITHM IN THE TLC-IIPLUS.
Current openFDA PMA Record#
- Device
- TLC-2PLUS PORTABLE VAD DRIVER
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S043
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2010-03-30
- Decision code
- APPR
- Date received
- 2010-02-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A FIRMWARE MODIFICATION TO THE OCCLUSION ALARM ALGORITHM IN THE TLC-IIPLUS.