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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nametemporary non-roller type cardiac support blood pump
ApplicantABIOMED, INC.
PMA NumberP140003
Supplement NumberS003
Date Received06/24/2015
Decision Date07/08/2015
Product Code
OZD[ Registered Establishments with OZD ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implement a change to the manufacturing procedure of the motor stator assembly.