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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTHORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP870072
Supplement NumberS027
Date Received01/12/2004
Decision Date08/03/2004
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the thoratec implantable ventricular assist device (ivad) as an alternate vad blood pump for use in the approved thoratec ventricular assist device system. The device, as modified, will be marketed under the trade name thoratec implantable ventricular assist device and is indicated for use in bridge to transplant patients who meet all of the following criteria: candidate for cardiac transplantation, imminent risk of dying before donor heart procurement, dependence on, or incomplete response to, continued vasopressor support. It is also indicated for postcardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass. In addition, the ivad is designed to be compatible with both the dual driver console and tlc-ii portable vad driver.
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