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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(TM) VENA CAVA FILTER
Generic NameFILTER, INTRAVASCULAR, CARDIOVASCULAR
Regulation Number870.3375
ApplicantCook, Inc.
P.O. Box 489
Bloomington, IN 47402
PMA NumberP850049
Supplement NumberS008
Date Received06/13/2000
Decision Date02/13/2002
Reclassified Date05/01/2000
Product Code DTK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK INC., BLOOMINGTON, INDIANA.
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