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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 (CVS) SET
Classification Namecatheter, sampling, chorionic villus
Generic Namechorionic villus sampling set
ApplicantCOOK OB/GYN
PMA NumberP900007
Supplement NumberS002
Date Received01/04/2000
Decision Date06/12/2000
Product Code
LLX[ Registered Establishments with LLX ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a smaller size cvs set (5. 3 fr, 24 cm).
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