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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTCI HEARTMATE IP LVAS
Generic NameVentricular (assist) bypass
ApplicantTHORATEC CORP.
6035 STONERIDGE DR.
PLEASANTON, CA 94588
PMA NumberP920014
Supplement NumberS008
Date Received03/17/1999
Decision Date03/25/1999
Withdrawal Date 10/03/2014
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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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