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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 AB5000 CIRCULATORY SUPPORT SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular support system
ApplicantABIOMED CARDIOVASCULAR, INC.
PMA NumberP900023
Supplement NumberS042
Date Received12/22/2004
Decision Date03/23/2005
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 a change to only the ab5000 circulatory support system that will allow the user an alternate means of reducing blood flow during weaning by adjusting the level of vacuum applied to the ab5000 blood pump.
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