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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 N100PC LVAS WITH OPTIONAL EPTFE INFLOW CONDUIT
Generic NameVentricular (assist) bypass
ApplicantWorldheart, Inc.
7799 Pardee Ln.
Oakland, CA 94621
PMA NumberP980012
Supplement NumberS003
Date Received06/11/2002
Decision Date01/10/2003
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 OPTIONAL USE OF THE RE-DESIGNED EPTFE INFLOW CONDUIT WITH THE NOVACOR N100PC LVAS DEVICE SYSTEM.
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