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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(R) 1000A IP LVAD
Generic NameVentricular (assist) bypass
ApplicantThoratec Corp
6035 Stoneridge Dr.
Pleasanton, CA 94588
PMA NumberP920014
Supplement NumberS003
Date Received12/04/1995
Decision Date04/12/1996
Withdrawal Date10/03/2014
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGE IN THE DESIGN OF THE NON-BLOOD CONTACTING TITANIUM COMPONENTS USED IN THE INFLOW AND OUTFLOW VALVE CONDUITS AND IN THE OUTFLOW GRAFT CONDUIT
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