PMA P870072S018
- Device
- THORATEC VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S018
- Product code
- DSQ
- Decision date
- 2002-04-18
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR UPGRADING THE EMBEDDED SOFTWARE (FIRMWARE) FOR THE TLC-II PORTABLE VAD DRIVER FROM VERSION 4.03 TO VERSION 4.11.
Current openFDA PMA Record#
- Device
- THORATEC VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S018
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2002-04-18
- Decision code
- APPR
- Date received
- 2001-10-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR UPGRADING THE EMBEDDED SOFTWARE (FIRMWARE) FOR THE TLC-II PORTABLE VAD DRIVER FROM VERSION 4.03 TO VERSION 4.11.