Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
|
Device | NOVACOR LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | WORLD HEART, INC. 7799 PARDEE LN. OAKLAND, CA 94621 |
PMA Number | P980012 |
Date Received | 04/24/1998 |
Decision Date | 09/29/1998 |
Withdrawal Date
|
07/15/2011 |
Product Code |
DSQ |
Docket Number | 99M-2605 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S003 S005 S006 |
|
|