PMA P870072S027

Device: THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S027
Product code: DSQ
Decision date: 2004-08-03
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR THE THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) AS AN ALTERNATE VAD BLOOD PUMP FOR USE IN THE APPROVED THORATEC VENTRICULAR ASSIST DEVICE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE AND IS INDICATED FOR USE IN BRIDGE TO TRANSPLANT PATIENTS WHO MEET ALL OF THE FOLLOWING CRITERIA: CANDIDATE FOR CARDIAC TRANSPLANTATION, IMMINENT RISK OF DYING BEFORE DONOR HEART PROCUREMENT, DEPENDENCE ON, OR INCOMPLETE RESPONSE TO, CONTINUED VASOPRESSOR SUPPORT. IT IS ALSO INDICATED FOR POSTCARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS. IN ADDITION, THE IVAD IS DESIGNED TO BE COMPATIBLE WITH BOTH THE DUAL DRIVER CONSOLE AND TLC-II PORTABLE VAD DRIVER.

Current openFDA PMA Record#

Device: THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S027
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2004-08-03
Decision code: APPR
Date received: 2004-01-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) AS AN ALTERNATE VAD BLOOD PUMP FOR USE IN THE APPROVED THORATEC VENTRICULAR ASSIST DEVICE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE AND IS INDICATED FOR USE IN BRIDGE TO TRANSPLANT PATIENTS WHO MEET ALL OF THE FOLLOWING CRITERIA: CANDIDATE FOR CARDIAC TRANSPLANTATION, IMMINENT RISK OF DYING BEFORE DONOR HEART PROCUREMENT, DEPENDENCE ON, OR INCOMPLETE RESPONSE TO, CONTINUED VASOPRESSOR SUPPORT. IT IS ALSO INDICATED FOR POSTCARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS. IN ADDITION, THE IVAD IS DESIGNED TO BE COMPATIBLE WITH BOTH THE DUAL DRIVER CONSOLE AND TLC-II PORTABLE VAD DRIVER.