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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 Dr.
Danvers, MA 01923
PMA NumberP900023
Supplement NumberS020
Date Received12/06/1996
Decision Date12/31/1996
Withdrawal Date02/01/2018
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGING THE TUBING DIAMETER OF THE TUBES LEADING TO/FROM THE LEFT SIDE FLOW TRANSDUCER FROM 1/4 INCH TO 1/16 INCH ID (INNDER DIAMETER) AND CHANGING THE CONSOLE COOLING FAN FROM ONE HAVING A CAPACITY OF 94 CFM (CUBIC FEET PER MINUTE) TO ONE HAVING A CAPACITY OF 55 CFM.
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