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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecatheter, sampling, chorionic villus
Generic Namechorionic villus sampling set
ApplicantCOOK OB/GYN
PMA NumberP900007
Date Received02/01/1990
Decision Date09/30/1994
Product Code
LLX[ Registered Establishments with LLX ]
Docket Number 94M-0364
Notice Date 11/14/1994
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S004 S005 S006