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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® Ventricular Assist System
Generic NameVentricular (assist) bypass
8200 Coral SeaSt. N.E.
Mounds View, MN 55112
PMA NumberP100047
Supplement NumberS197
Date Received04/18/2022
Decision Date05/10/2022
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of a holding fixture during assembly of the battery pack, change in the tape used during assembly, and revision of the final inspection procedure.