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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.
 
DeviceCOOK CHORIONIC VILLUS SAMPLING SET
Generic NameCatheter, sampling, chorionic villus
ApplicantCook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402
PMA NumberP900007
Supplement NumberS006
Date Received12/02/2008
Decision Date03/05/2009
Product Code LLX 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFICATION TO THE OBTURATOR HANDLE AND THE TECHNIQUE FOR AFFIXING IT TO THE OBTURATOR WIRE.
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