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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 NumberS005
Date Received11/17/2008
Decision Date04/02/2009
Product Code LLX 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF ECHOTIP BANDING TO THE DISTAL TWO CENTIMETERS OF THE OBTURATOR.
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