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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 Name42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF
Classification Nameventricular (assisst) bypass
Generic Nameventricular support system
ApplicantABIOMED CARDIOVASCULAR, INC.
PMA NumberP900023
Supplement NumberS044
Date Received01/11/2006
Decision Date07/07/2006
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 design changes to integrate the previously approved 42 fr. Ventricular/atrial cannula and previously approved sewing cuff accessory. The device, as modified, will be marketed under the trade name 42 fr. Ventricular cannula with integrated sewing cuff and is indicated for use with the bvs 5000 biventricular support system and with the ab5000 circulatory support system.
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