TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

FDA Premarket Approval P890024 S003

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.

Pre-market Approval Supplement Details

DeviceTROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER
Generic NameCatheter, Sampling, Chorionic Villus
ApplicantSMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
Date Received1991-05-28
Decision Date1992-04-21
PMAP890024
SupplementS003
Product CodeLLX 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 Kit St. keene, NH 03431

Supplemental Filings

Supplement NumberDateSupplement Type
P890024Original Filing
S005 1992-05-04 Normal 180 Day Track
S004 1991-05-30 Special (immediate Track)
S003 1991-05-28 Normal 180 Day Track
S002 1990-08-28 Normal 180 Day Track
S001 1990-08-14 Normal 180 Day Track
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