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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
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
ABIOMED CARDIOVASCULAR, INC.
22 cherry hill drive
danvers, MA 01923
PMA NumberP900023
Supplement NumberS013
Date Received08/31/1994
Decision Date01/29/1996
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR INCREASING THE LEFT SIDE FLOW CAPACITY OF THE ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM BY APPROXIMATELY 1 LITE/MINUTE (I.E., FROM 5 LITERS/MINUTE TO APPROXIMATELY 6 LITERS/MINUTE
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