PMA P920014S006
- Device
- TCI HEARTMATE(R) 1000A IP LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S006
- Product code
- DSQ
- Decision date
- 1997-05-22
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A CHANGE TO THE INTERIM PERCUTANEOUS DRIVE LINE DESIGN
Current openFDA PMA Record#
- Device
- TCI HEARTMATE(R) 1000A IP LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S006
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1997-05-22
- Decision code
- APPR
- Date received
- 1997-05-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE INTERIM PERCUTANEOUS DRIVE LINE DESIGN