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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 IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)
Generic NameVentricular (assist) bypass
ApplicantTHORATEC LABORATORIES CORP.
2023 EIGHTH ST.
BERKELEY, CA 94710
PMA NumberP870072
Supplement NumberS027
Date Received01/06/2004
Decision Date08/03/2004
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 THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) AS AN ALTERNATE VAD BLOOD PUMP FOR USE IN THE APPROVED THORATEC VENTRICULAR ASSIST DEVICE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE AND 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. IN ADDITION, THE IVAD IS DESIGNED TO BE COMPATIBLE WITH BOTH THE DUAL DRIVER CONSOLE AND TLC-II PORTABLE VAD DRIVER.
Post-Approval StudyShow Report Schedule and Study Progress
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