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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 and CP with SmartAssist
Generic NameTemporary non-roller type left heart support blood pump
ApplicantAbiomed, Inc.
22 Cherry Hill Dr.
Danvers, MA 01923
PMA NumberP140003
Supplement NumberS110
Date Received03/28/2023
Decision Date04/27/2023
Product Code OZD 
Advisory Committee Cardiovascular
Clinical TrialsNCT05820451
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the Impella Real-World Surveillance of patients using Sodium Bicarbonate. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval orders for P140003/S088 and P170011/S035.
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