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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.
 
DeviceHEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
Generic NameVentricular (assist) bypass
ApplicantMedtronic
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP100047
Supplement NumberS036
Date Received01/22/2014
Decision Date02/21/2014
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  
USE OF AN ALTERNATE SUPPLIER FOR AN ALTERNATE MOSFET USED IN THE HEARTWARE VENTRICULAR ASSIST SYSTEM.
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