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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
Applicant
Medtronic
8200 coral seast. n.e.
mounds view, MN 55112
PMA NumberP100047
Supplement NumberS164
Date Received05/26/2020
Decision Date06/22/2020
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of updates to the inspection methodologies for components of the HVAD system (Front and Rear Ceramic Discs).
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