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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameNOVACOR LVAS
Classification Nameventricular (assisst) bypass
Generic Nameleft ventricular assist system
ApplicantWORLD HEART, INC.
PMA NumberP980012
Date Received04/24/1998
Decision Date09/29/1998
Withdrawal Date 07/15/2011
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number 99M-2605
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the novacor(r) lvas. This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The lvas is indicated for use both inside and outside the hospital.
Approval Order Approval Order
Supplements: S001 S003 S005 S006 
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