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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 NumberS001
Date Received01/15/1998
Decision Date07/08/1998
Product Code LLX 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for removing the condition of approval regarding collection of individual outcome data from each CVS case.
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