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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.
 
DeviceHeartMate II® Left Ventricular Assist System
Generic Nameventricular (assist) bypass
ApplicantAbbott Medical
6035 stoneridge drive
pleasanton, CA 94588
PMA NumberP060040
Supplement NumberS086
Date Received04/18/2022
Decision Date06/23/2022
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an alternate drop-in replacement battery cell within the Battery Stack sub-assembly.
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