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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.
 
DeviceTROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER
Classification Namecatheter, sampling, chorionic villus
Generic Namecatheter, sampling, chorionic villus
Applicant
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 kit st.
keene, NH 03431
PMA NumberP890024
Supplement NumberS003
Date Received05/28/1991
Decision Date04/21/1992
Product Code
LLX
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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