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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 SmartAssist System, Impella 5.0 System, Impella LD System,Impella
Generic NameTemporary non-roller type left heart support blood pump
ApplicantABIOMED, INC.
22 CHERRY HILL DR.
DANVERS, MA 01923
PMA NumberP140003
Supplement NumberS088
Date Received08/05/2021
Decision Date04/19/2022
Product Code OZD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for revising the Instructions for Use to allow the use of sodium bicarbonate (25 or 50 mEq/L) as an alternative to heparin (25 or 50 U/mL) in the purge fluid during clinical use of the Impella catheters in patients intolerant to heparin or in whom heparin is contraindicated.
Post-Approval StudyShow Report Schedule and Study Progress
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