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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 NameAB5000/BVS 5000 CIRCULATORY SUPPORT SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular support system
ApplicantABIOMED CARDIOVASCULAR, INC.
PMA NumberP900023
Supplement NumberS046
Date Received10/26/2006
Decision Date04/24/2007
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the ab5000 ventricle cannula restraint system, extended shelf life (2 years) for the ab5000 ventricle, and reclassification of a precaution to a warning for the bvs 5000.
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