PMA P920014S003
- Device
- TCI HEARTMATE(R) 1000A IP LVAD
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S003
- Product code
- DSQ
- Decision date
- 1996-04-12
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR CHANGE IN THE DESIGN OF THE NON-BLOOD CONTACTING TITANIUM COMPONENTS USED IN THE INFLOW AND OUTFLOW VALVE CONDUITS AND IN THE OUTFLOW GRAFT CONDUIT
Current openFDA PMA Record#
- Device
- TCI HEARTMATE(R) 1000A IP LVAD
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S003
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1996-04-12
- Decision code
- APPR
- Date received
- 1995-12-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGE IN THE DESIGN OF THE NON-BLOOD CONTACTING TITANIUM COMPONENTS USED IN THE INFLOW AND OUTFLOW VALVE CONDUITS AND IN THE OUTFLOW GRAFT CONDUIT