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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
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
ABIOMED CARDIOVASCULAR, INC.
22 cherry hill drive
danvers, MA 01923
PMA NumberP900023
Supplement NumberS034
Date Received11/15/2000
Decision Date03/12/2001
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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