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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 (LVAS)
Generic Nameventricular (assist) bypass
ApplicantAbbott Medical
6035 stoneridge drive
pleasanton, CA 94588
PMA NumberP060040
Supplement NumberS082
Date Received12/14/2021
Decision Date01/12/2022
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for addendums to Instructions for Use and Patient Handbook for HeartMate 3 Left Ventricular Assist System (LVAS) and HeartMate II Left Ventricular Assist System (LVAS)
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