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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 NameBIRD'S NEST VENA CAVA FILTER
Classification Namefilter, intravascular, cardiovascular
Generic Namevena cava filter
Regulation Number870.3375
ApplicantCOOK, INC.
PMA NumberP850049
Supplement NumberS009
Date Received01/05/2006
Decision Date02/03/2006
Product Code
DTK[ Registered Establishments with DTK ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the sterilization type within the same facility.
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