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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCOOK CHORIONIC VILLUS SAMPLING SET
Classification Namecatheter, sampling, chorionic villus
Generic Namechorionic villus sampling set
ApplicantCOOK UROLOGICAL, INC.
PMA NumberP900007
Supplement NumberS004
Date Received04/09/2008
Decision Date05/08/2008
Product Code
LLX[ Registered Establishments with LLX ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the sterilization agent used in processing the cook chorionic villus sampling set.
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