PMA P920014S014
- Device
- TCI HEARTMATE VE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S014
- Product code
- DSQ
- Decision date
- 2001-03-02
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL TO CHANGE THE METHOD OF CONNECTING THE PERCUTANEOUS CONTROLLER CABLE (P/N 28702) TO THE VE SYSTEM CONTROLLER (C/N 1216).
Current openFDA PMA Record
- Device
- TCI HEARTMATE VE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S014
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2001-03-02
- Decision code
- APPR
- Date received
- 2000-12-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO CHANGE THE METHOD OF CONNECTING THE PERCUTANEOUS CONTROLLER CABLE (P/N 28702) TO THE VE SYSTEM CONTROLLER (C/N 1216).