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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 and Impella RP 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 NumberS040
Date Received05/02/2022
Decision Date10/28/2022
Product Code PYX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the use of an alternative programmed microcontroller.
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