PMA P870072S012

Device: THORATEC VENTRICULAR ASIST DEVICE
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S012
Product code: DSQ
Decision date: 2001-06-01
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR THE ADDITION OF THE TLC-II PORTABLE PNEUMATIC DRIVER TO THE THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE SYSTEM. THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED TO BE INTERCHANGEABLE WITH THE DUAL DRIVE CONSOLE IN THE (CURRENTLY APPROVED) THORATEC PARACORPOREAL VENTRICULAR DEVICE SYSTEM FOR EITHER BRIDGE TO TRANSPLANT PATIENTS OR FOR POSTCARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS. THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED FOR USE EITHER IN THE HOSPITAL OR IN A MEDICALLY MONITORED RESIDENCE FACILITY. IN ADDITION, THE TLC-II PORTABLE PNEUMATIC DRIVER CAN BE USED TO ALLOW SUITABLY QUALIFIED PATIENTS TO TAKE OFF-SITE EXCURSIONS WITHIN A TWO-HOUR TRAVEL RADIUS OF THE HOSPITAL IN THE COMPANY OF A TRAINED CAREGIVER.

Current openFDA PMA Record#

Device: THORATEC VENTRICULAR ASIST DEVICE
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S012
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2001-06-01
Decision code: APPR
Date received: 2000-09-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF THE TLC-II PORTABLE PNEUMATIC DRIVER TO THE THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE SYSTEM. THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED TO BE INTERCHANGEABLE WITH THE DUAL DRIVE CONSOLE IN THE (CURRENTLY APPROVED) THORATEC PARACORPOREAL VENTRICULAR DEVICE SYSTEM FOR EITHER BRIDGE TO TRANSPLANT PATIENTS OR FOR POSTCARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS. THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED FOR USE EITHER IN THE HOSPITAL OR IN A MEDICALLY MONITORED RESIDENCE FACILITY. IN ADDITION, THE TLC-II PORTABLE PNEUMATIC DRIVER CAN BE USED TO ALLOW SUITABLY QUALIFIED PATIENTS TO TAKE OFF-SITE EXCURSIONS WITHIN A TWO-HOUR TRAVEL RADIUS OF THE HOSPITAL IN THE COMPANY OF A TRAINED CAREGIVER.