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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 PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER
Generic NameVentricular (assist) bypass
ApplicantTHORATEC LABORATORIES CORP.
2023 EIGHTH ST.
BERKELEY, CA 94710
PMA NumberP870072
Supplement NumberS026
Date Received07/03/2003
Decision Date11/26/2003
Withdrawal Date 10/05/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO EXPAND THE INDICATIONS FOR USE TO INCLUDE TRANSPORT OF PATIENTS IN FIXED WING AIRCRAFT AND IN HELICOPTERS. THIS 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 POSTCARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS. WHEN USED WITH THE TLC-II PORTABLE PNEUMATIC DRIVER, THE PVAD IS INTENDED FOR USE FOR TRANSPORTATION OF VAD PATIENTS VIA GROUND AMBULANCE, FIXED WING AIRCRAFT OR HELICOPTER. 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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