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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 Flex with SmartAssist
Generic NameTemporary non-roller type right heart support blood pump
Regulation Number870.4360
ApplicantAbiomed, Inc.
22 Cherry Hill Dr.
Danvers, MA 01923
PMA NumberP170011
Supplement NumberS050
Date Received05/26/2023
Decision Date06/23/2023
Product Code PYX 
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 updates to the Instructions for Use (IFU) to include warning statements and clinical recommendations related to risk of thrombus formation or deposition in the Impella RP Flex with SmartAssist when indwelling venous lines or cannulas are present.
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