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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
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 NumberS001
Date Received08/14/1990
Decision Date08/17/1990
Product Code
LLX[ Registered Establishments with 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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