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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.
 
DeviceBIRD'S NEST VENA CAVA FILTER
Generic NameFILTER, INTRAVASCULAR, CARDIOVASCULAR
Regulation Number870.3375
ApplicantCook, Inc.
P.O. Box 489
Bloomington, IN 47402
PMA NumberP850049
Supplement NumberS009
Date Received01/05/2006
Decision Date02/03/2006
Reclassified Date05/01/2000
Product Code DTK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE STERILIZATION TYPE WITHIN THE SAME FACILITY.
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