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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.
 
DeviceImpella 5.0
Generic NameTemporary non-roller type left heart support blood pump
ApplicantABIOMED, INC.
22 CHERRY HILL DR.
DANVERS, MA 01923
PMA NumberP140003
Supplement NumberS049
Date Received02/27/2019
Decision Date05/06/2019
Product Code OZD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a modification to the labeling to extend the duration of support from 6 days to 14 days.
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