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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 DEVICE SYSTEM
Generic NameVentricular (assist) bypass
ApplicantMedtronic
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP100047
Supplement NumberS029
Date Received08/07/2013
Decision Date09/06/2013
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  
REPLACEMENT OF THE CURRENT STERILIZATION PROCESS CHALLENGE DEVICE WITH AN ALTERNATIVE PROCESS CHALLENGE DEVICE FOR MONITORING OF ETHYLENE OXIDE STERILIZED COMPONENTS OF THE DEVICE.
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