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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, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist
Generic NameTemporary non-roller type left heart support blood pump
ApplicantAbiomed, Inc.
22 Cherry Hill Dr.
Danvers, MA 01923
PMA NumberP140003
Supplement NumberS072
Date Received03/30/2020
Decision Date08/04/2020
Product Code OZD 
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: 1) a new design for the Impella 2.5, Impella CP, and Impella CP with SmartAssist pigtail subcomponent; 2) the addition of a second supplier for the new pigtail design; and 3) a change in material and supplier of the encapsulant on the optical sensor used on the Impella CP with SmartAssist and the Impella 5.5 with SmartAssist catheters.
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