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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.
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
8200 coral seast. n.e.
mounds view, MN 55112
PMA NumberP100047
Supplement NumberS044
Date Received05/29/2014
Decision Date06/27/2014
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updates to the instructions for use and patient manual of the device to include information related to battery performance.