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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHORATEC VENTRICULAR ASIST DEVICE
Generic NameVentricular (assist) bypass
ApplicantTHORATEC LABORATORIES CORP.
2023 EIGHTH ST.
BERKELEY, CA 94710
PMA NumberP870072
Supplement NumberS012
Date Received09/25/2000
Decision Date06/01/2001
Withdrawal Date 10/05/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
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