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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.
 
DeviceNOVACOR N100PCQ LVAS
Generic NameVentricular (assist) bypass
ApplicantWorldheart, Inc.
7799 Pardee Ln.
Oakland, CA 94621
PMA NumberP980012
Supplement NumberS005
Date Received01/27/2003
Decision Date01/02/2004
Withdrawal Date07/15/2011
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR SEVERAL SPECIFIC ENGINEERING ENHANCEMENTS TO THE IMPLANTED (PUMP/DRIVE UNIT, BLOOD CONDUITS, AND PERCUTANEOUS LEAD) COMPONENTS OF THE NOVACOR N100PC LVAS SYSTEM AS WELL AS MODIFICATIONS TO THE SOFTWARE TO UPGRADE TO THE N100PCQ LVAS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NOVACOR N100PCQ LVAS SYSTEM AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FUNCTION FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL.
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