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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
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 NumberS003
Date Received12/18/2017
Decision Date02/16/2018
Product Code PYX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.
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