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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 NameTCI HEARTMATE(R) 1000A IP LVAD
Classification Nameventricular (assisst) bypass
Generic Nameleft ventricular assist device
ApplicantTHERMO CARDIOSYSTEMS, INC.
PMA NumberP920014
Supplement NumberS001
Date Received12/19/1994
Decision Date12/16/1999
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to use cardioflex(r) instead of biomer for manufacturing the diaphragms for the device. The device is indicated for use as a bridge to transplantation in cardiac trnasplant candidates at risk of imminent death from nonreversible left ventricular failure.
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