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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 NumberS023
Date Received12/03/2002
Decision Date11/20/2003
Withdrawal Date 10/05/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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