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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.
 
DeviceGIANTURCO-ROEHM BIRD'S NEST(TM) 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 NumberS008
Date Received06/13/2000
Decision Date02/13/2002
Product Code
DTK[ Registered Establishments with DTK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at cook inc. , bloomington, indiana.
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