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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.
 
DeviceBIRD'S NEST VENA CAVA FILTER
Classification Namefilter, intravascular, cardiovascular
Generic Namefilter, intravascular, cardiovascular
Regulation Number870.3375
Applicant
COOK, INC.
p.o. box 489
bloomington, IN 47402
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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