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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 IP LVAS
Classification Nameventricular (assisst) bypass
Generic Nameleft ventricular assist device
ApplicantTHERMO CARDIOSYSTEMS, INC.
PMA NumberP920014
Supplement NumberS008
Date Received03/17/1999
Decision Date03/25/1999
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify section 9. 6 of the current directions for use to include instructions for adding an additional retaining suture from the outflow graft screw ring to the outflow elbow screw ring to secure the outflow graft and outflow conduit.
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