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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 OB/GYN
PMA NumberP900007
Supplement NumberS001
Date Received01/15/1998
Decision Date07/08/1998
Product Code
LLX[ Registered Establishments with LLX ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removing the condition of approval regarding collection of individual outcome data from each cvs case.
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