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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 2.5 & Impella CP Systems
Generic NameTemporary non-roller type left heart support blood pump
ApplicantABIOMED, INC.
PMA NumberP140003
Supplement NumberS027
Date Received09/29/2017
Decision Date02/08/2018
Product Code OZD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for removing the reference to “depressed left ventricular ejection fraction” from the indications for use statement.