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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 HVAD System
Generic NameVentricular (assist) bypass
ApplicantMedtronic
8200 Coral SeaSt. N.E.
Mounds View, MN 55112
PMA NumberP100047
Supplement NumberS174
Date Received02/09/2021
Decision Date08/12/2021
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the acceptance activities for the O-rings in the HVAD Driveline Splice Kit.
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