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.