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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
Generic Nameventricular support system
ApplicantABIOMED CARDIOVASCULAR, INC.
PMA NumberP900023
Supplement NumberS020
Date Received12/06/1996
Decision Date12/31/1996
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 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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