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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER
Generic NameCatheter, sampling, chorionic villus
ApplicantSmiths Industries Medical Systems, Inc.
15 Kit St.
Keene, NH 03431
PMA NumberP890024
Supplement NumberS004
Date Received05/30/1991
Decision Date04/21/1992
Withdrawal Date03/10/2008
Product Code LLX 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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