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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, Impella RP with SmartAssist and 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 NumberS043
Date Received07/20/2022
Decision Date08/19/2022
Product Code PYX 
Advisory Committee Cardiovascular
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 protocol for the post-approval study (PAS) protocol.
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