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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 BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Generic NameVentricular (assist) bypass
ApplicantAbiomed Cardiovascular, Inc.
22 Cherry Hill Dr.
Danvers, MA 01923
PMA NumberP900023
Supplement NumberS034
Date Received11/15/2000
Decision Date03/12/2001
Withdrawal Date02/01/2018
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO REVISE THE LABELING TO INCLUDE CANNULATION OF THE LEFT VENTRICULAR APEX WITH ANY OF THE ATRIAL CANNULAE.
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