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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 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5 with Smart A
Generic NameTemporary non-roller type left heart support blood pump
ApplicantAbiomed, Inc.
22 Cherry Hill Dr.
Danvers, MA 01923
PMA NumberP140003
Supplement NumberS135
Date Received10/23/2025
Decision Date02/06/2026
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a modification to the Instructions for Use to allow sodium bicarbonate to be used in the purge fluid for the Impella catheters if heparin should not be used per the physician’s clinical judgement.
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