PMA P920014S001
- Device
- TCI HEARTMATE(R) 1000A IP LVAD
- Applicant
- THORATEC CORP.
- PMA number
- P920014
- Supplement
- S001
- Product code
- DSQ
- Decision date
- 1999-12-16
- Generic name
- Ventricular (assist) Bypass
- Approval order statement
- Approval To Use Cardioflex(R) Instead Of Biomer For Manufacturing The Diaphragms For The Device. The Device Is Indicated For Use As A Bridge To Transplantation In Cardiac Trnasplant Candidates At Risk Of Imminent Death From Nonreversible Left Ventricular Failure.
Current openFDA PMA Record
- Device
- TCI HEARTMATE(R) 1000A IP LVAD
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S001
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1999-12-16
- Decision code
- APPR
- Date received
- 1994-12-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to use Cardioflex(R) instead of Biomer for manufacturing the diaphragms for the device. The device is indicated for use as a bridge to transplantation in cardiac trnasplant candidates at risk of imminent death from nonreversible left ventricular failure.