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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 CP, Impella CP with SmartAssist, Impella 2.5, Impella 5.0/LD, Impella 5.5 with SmartAssist
Generic NameTemporary non-roller type left heart support blood pump
ApplicantAbiomed, Inc.
22 Cherry Hill Dr.
Danvers, MA 01923
PMA NumberP140003
Supplement NumberS116
Date Received12/08/2023
Decision Date01/05/2024
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of a warning statement related to ethylene oxide residuals to the Impella systems instructions for use.
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