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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 NameGIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER
Classification Namefilter, intravascular, cardiovascular
Generic Namevena cava filter
Regulation Number870.3375
ApplicantCOOK, INC.
PMA NumberP850049
Supplement NumberS006
Date Received10/07/1998
Decision Date12/21/1998
Product Code
DTK[ Registered Establishments with DTK ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the packaging.
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