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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.
 
DeviceAB PORTABLE DRIVER
Generic NameVentricular (assist) bypass
ApplicantABIOMED CARDIOVASCULAR, INC.
22 CHERRY HILL DRIVE
DANVERS, MA 01923
PMA NumberP900023
Supplement NumberS049
Date Received08/01/2008
Decision Date03/17/2009
Withdrawal Date 02/01/2018
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR IN-HOSPITAL USE OF THE DEVICE.
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