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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, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist Systems
Generic NameTemporary non-roller type left heart support blood pump
ApplicantABIOMED, INC.
PMA NumberP140003
Supplement NumberS117
Date Received12/18/2023
Decision Date12/21/2023
Product Code OZD 
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 changes to the device labeling for the continued safe use of Impella catheters in regard to ventricular perforation and cotton fiber ingestion.