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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 NumberS004
Date Received05/30/1991
Decision Date04/21/1992
Product Code
LLX[ Registered Establishments with LLX ]
Advisory Committee Obstetrics/Gynecology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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