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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.
 
DeviceHEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM
Generic NameVentricular (assist) bypass
ApplicantThoratec Corp
6035 Stoneridge Dr.
Pleasanton, CA 94588
PMA NumberP920014
Supplement NumberS027
Date Received05/30/2007
Decision Date06/29/2007
Withdrawal Date10/03/2014
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ALTERNATE SUPPLIER FOR THE POLYMER USED TO MANUFACTURE THE DIAPHRAGM USED IN THE DEVICE.
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