PMA P920014S010
- Device
- HEARTMATE IP AND VE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S010
- Product code
- DSQ
- Decision date
- 1999-12-10
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval to introduce self-locking screw rings to attach the pump elbows to the two valved conduits and the outflow valved conduit to the outflow graft.
Current openFDA PMA Record#
- Device
- HEARTMATE IP AND VE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S010
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1999-12-10
- Decision code
- APPR
- Date received
- 1999-12-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to introduce self-locking screw rings to attach the pump elbows to the two valved conduits and the outflow valved conduit to the outflow graft.