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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER
Generic NameFILTER, INTRAVASCULAR, CARDIOVASCULAR
Regulation Number870.3375
ApplicantCook, Inc.
P.O. Box 489
Bloomington, IN 47402
PMA NumberP850049
Supplement NumberS007
Date Received08/20/1999
Decision Date09/14/1999
Reclassified Date05/01/2000
Product Code DTK 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to add a Patient Guide booklet to each device shipment.
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