PMA P870072S023

Device: THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S023
Product code: DSQ
Decision date: 2003-11-20
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR THE USE OF THE VAD SYSTEM IN THE HOME ENVIRONMENT AND FOR THE ADDITION OF TWO ACCESSORIES FOR THE THORATEC VAD SYSTEM: THE MOBILE COMPUTER AND THE CAR POWER ADAPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE SYSTEM AND TLC-II PORTABLE VAD DRIVER. THE PVAD 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 POST CARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS. THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL OR FOR TRANSPORTATION OF VAD PATIENTS VIA GROUND AMBULANCE.

Current openFDA PMA Record#

Device: THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S023
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2003-11-20
Decision code: APPR
Date received: 2002-12-03
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE USE OF THE VAD SYSTEM IN THE HOME ENVIRONMENT AND FOR THE ADDITION OF TWO ACCESSORIES FOR THE THORATEC VAD SYSTEM: THE MOBILE COMPUTER AND THE CAR POWER ADAPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE SYSTEM AND TLC-II PORTABLE VAD DRIVER. THE PVAD 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 POST CARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS. THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL OR FOR TRANSPORTATION OF VAD PATIENTS VIA GROUND AMBULANCE.