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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.
 
DeviceWORLD HEART NOVACOR N100PC AND N100PCQ :VAS
Generic NameVentricular (assist) bypass
ApplicantWorldheart, Inc.
7799 Pardee Ln.
Oakland, CA 94621
PMA NumberP980012
Supplement NumberS006
Date Received03/10/2004
Decision Date07/21/2004
Withdrawal Date07/15/2011
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE DEVICE SYSTEM LABELING; SPECIFICALLY, CHANGES TO (ONLY) THE DEVICE RELIABILITY PORTION OF SECTION 7 (CLINICAL STUDY) OF THE PHYSICIAN'S MANUAL.
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