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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular support system
ApplicantABIOMED CARDIOVASCULAR, INC.
PMA NumberP900023
Supplement NumberS040
Date Received03/18/2004
Decision Date06/28/2004
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of two inflow cannulae (malleable 42 fr. And 32 fr. ) to be added to the currently approved cannulae used with the bvs5000 bi-ventricular support system and the ab5000 circulatory support system.
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