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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(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Classification Nameventricular (assisst) bypass
ApplicantABIOMED CARDIOVASCULAR, INC.
PMA NumberP900023
Supplement NumberS016
Date Received08/16/1995
Decision Date03/12/1996
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to a component in the bvs 5000 console, the honeywell solenoid valve , and to extend the recommended replacement itme.
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