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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 NumberS008
Date Received09/06/2018
Decision Date09/25/2018
Product Code PYX 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a design change to the optical version of the Automated Impella Controller, adding a cover over the pump plug receptacle.
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