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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 2.5 & Impella CP Systems
Classification Nametemporary non-roller type left heart support blood pump
Generic Nametemporary non-roller type left heart support blood pump
22 cherry hill dr.
danvers, MA 01923
PMA NumberP140003
Supplement NumberS027
Date Received09/29/2017
Decision Date02/08/2018
Product Code
OZD[ Registered Establishments with OZD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removing the reference to “depressed left ventricular ejection fraction” from the indications for use statement.