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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, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD
Generic NameTemporary non-roller type left heart support blood pump
ApplicantABIOMED, INC.
22 CHERRY HILL DR.
DANVERS, MA 01923
PMA NumberP140003
Supplement NumberS071
Date Received03/23/2020
Decision Date04/09/2020
Product Code OZD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implementing a semi-automated test fixture for the leakage current measurement test performed during the final inspection for the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, Impella LD, and Impella RP catheters.
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