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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.
 
DeviceTHORATEC HEARTMATE II LVAS
Generic NameVentricular (assist) bypass
ApplicantABBOTT MEDICAL
6035 Stoneridge Dr.
Pleasanton, CA 94588
PMA NumberP060040
Supplement NumberS002
Date Received11/20/2008
Decision Date12/03/2008
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A CAUTION STATEMENT ''WARNING: PRECLOT THEGRAFT!" TO THE PACKAGE LABELS FOR THE OUTFLOW GRAFT WITH BEND RELIEF (CATALOG# 102563) ANDINFLOW CONDUIT (CATALOG # 102564). THIS CAUTION STATEMENT IS TO HIGHLIGHT INFORMATION CURRENTLYFOUND IN THE HEARTMATE II INSTRUCTIONS FOR USE, SECTION 13.4, WHICH INSTRUCTS USERS TO PRE-CLOT THE TWO COMPONENTS PRIOR TO IMPLANTATION.
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