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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.
 
DeviceABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Generic NameVentricular (assist) bypass
ApplicantABIOMED CARDIOVASCULAR, INC.
22 CHERRY HILL DRIVE
DANVERS, MA 01923
PMA NumberP900023
Supplement NumberS025
Date Received11/24/1997
Decision Date03/13/1998
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
RecallsCDRH Recalls
Approval Order Statement  
Approval for four new 32 French atrial cannulae which are 90 degrees Bend with Lighthouse Tip, Straight with Lighthouse Tip, 90 degrees Bend with Beveled Tip, and Straight with Beveled Tip.
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