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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 RP System, Impella RP with SmartAssist System
Generic NameTemporary non-roller type right heart support blood pump
Regulation Number870.4360
ApplicantAbiomed, Inc.
22 Cherry Hill Drive
Danvers, MA 01923
PMA NumberP170011
Supplement NumberS035
Date Received08/05/2021
Decision Date04/19/2022
Product Code PYX 
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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